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Bassat Orellana Quique - One of the best experts on this subject based on the ideXlab platform.

  • Efficacy and Tolerability Outcomes of a Phase II, Randomized, Open-Label, Multicenter Study of a New Water-Dispersible Pediatric Formulation of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in African
    'American Society for Microbiology', 2018
    Co-Authors: Gargano Nicola, Madrid Lola, Valentini Giovanni, Halidou Tinto, Sirima Sodiomon, Tshefu Antoinette, Gesase Samwel, D'alessandro Umberto, Mtoro Ali, Bassat Orellana Quique
    Abstract:

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new Dispersible-Tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed Tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania. Primary efficacy endpoint was the PCR-corrected adequate clinical and parasitological response (ACPR) at day 28. Analysis was performed for the intention-to-treat (ITT) and per-protocol (PP) populations. A total of 201 patients received the Dispersible-Tablet formulation, and 99 received the conventional one administered as crushed Tablets. At day 28, the PCR-corrected ACPRs were 86.9% (ITT) and 98.3% (PP) in the Dispersible-Tablet group and 84.9% (ITT) and 100% (PP) in the crushed-Tablet group. At day 42, these values were 85.9% (ITT) and 96.5% (PP) in the Dispersible-Tablet group and 82.8% (ITT) and 96.4% (PP) in the crushed-Tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (P = 0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of adverse events and was consistent with that expected in African infants with malaria. A standard 3-day treatment with the new Dispersible DHA/PQP formulation is as efficacious as the currently used Tablet in African infants and has a comparable safety profile.Sin financiación4.715 JCR (2018) Q1, 28/133 Microbiology, 27/267 Pharmacology & Pharmacy2.096 SJR (2018) Q1, 29/298 Infectious Diseases, 11/268 Pharmacology (medical), 21/335 PharmacologyNo data IDR 2018UE

  • A new water-Dispersible paediatric formulation of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in African infants: efficacy and tolerability outcome
    'American Society for Microbiology', 2017
    Co-Authors: Gargano Nicola, Madrid Lola, Valentini Giovanni, Alessandro, Umberto D', Halidou Tinto, Sirima Sodiomon, Tshefu Antoinette, Mtoro, Ali Takadir, Gesase Samwel, Bassat Orellana Quique
    Abstract:

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but paediatric friendly formulations for the treatments of infants are scarce. We aimed to evaluate the efficacy and safety of a new Dispersible Tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed Tablet (Eurartesim(R)) in the treatment of infants with uncomplicated P. falciparum malaria.Reported here are the results of a large phase II, randomized, open label, multicenter trial conducted in African infants (6-12 months of age) from Mozambique, Burkina Faso, The Gambia, DR-Congo and Tanzania. Primary efficacy endpoint was the PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at day 28. Analysis was performed for the Intention-To-Treat (ITT) and Per-Protocol (PP) populations.Two-hundred and one patients received the Dispersible Tablet formulation and 99 the conventional one administered as crushed Tablets. At day 28, the PCR-corrected ACPR was 86.9% (ITT) and 98.3% (PP) in the Dispersible Tablet group, and 84.9% (ITT) and 100% (PP) in the crushed Tablet group. At day 42, it was 85.9% (ITT) and 96.5% (PP) in the Dispersible Tablet group, and 82.8% (ITT) and 96.4% (PP) in the crushed Tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (p=0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of Adverse Events and was consistent with that expected in African infants with malaria.A standard three-day treatment with the new Dispersible DHA/PQP formulation is as efficacious as the currently used Tablet in African infants, and has a comparable safety profile

Gargano Nicola - One of the best experts on this subject based on the ideXlab platform.

  • Efficacy and Tolerability Outcomes of a Phase II, Randomized, Open-Label, Multicenter Study of a New Water-Dispersible Pediatric Formulation of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in African
    'American Society for Microbiology', 2018
    Co-Authors: Gargano Nicola, Madrid Lola, Valentini Giovanni, Halidou Tinto, Sirima Sodiomon, Tshefu Antoinette, Gesase Samwel, D'alessandro Umberto, Mtoro Ali, Bassat Orellana Quique
    Abstract:

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new Dispersible-Tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed Tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania. Primary efficacy endpoint was the PCR-corrected adequate clinical and parasitological response (ACPR) at day 28. Analysis was performed for the intention-to-treat (ITT) and per-protocol (PP) populations. A total of 201 patients received the Dispersible-Tablet formulation, and 99 received the conventional one administered as crushed Tablets. At day 28, the PCR-corrected ACPRs were 86.9% (ITT) and 98.3% (PP) in the Dispersible-Tablet group and 84.9% (ITT) and 100% (PP) in the crushed-Tablet group. At day 42, these values were 85.9% (ITT) and 96.5% (PP) in the Dispersible-Tablet group and 82.8% (ITT) and 96.4% (PP) in the crushed-Tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (P = 0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of adverse events and was consistent with that expected in African infants with malaria. A standard 3-day treatment with the new Dispersible DHA/PQP formulation is as efficacious as the currently used Tablet in African infants and has a comparable safety profile.Sin financiación4.715 JCR (2018) Q1, 28/133 Microbiology, 27/267 Pharmacology & Pharmacy2.096 SJR (2018) Q1, 29/298 Infectious Diseases, 11/268 Pharmacology (medical), 21/335 PharmacologyNo data IDR 2018UE

  • A new water-Dispersible paediatric formulation of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in African infants: efficacy and tolerability outcome
    'American Society for Microbiology', 2017
    Co-Authors: Gargano Nicola, Madrid Lola, Valentini Giovanni, Alessandro, Umberto D', Halidou Tinto, Sirima Sodiomon, Tshefu Antoinette, Mtoro, Ali Takadir, Gesase Samwel, Bassat Orellana Quique
    Abstract:

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but paediatric friendly formulations for the treatments of infants are scarce. We aimed to evaluate the efficacy and safety of a new Dispersible Tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed Tablet (Eurartesim(R)) in the treatment of infants with uncomplicated P. falciparum malaria.Reported here are the results of a large phase II, randomized, open label, multicenter trial conducted in African infants (6-12 months of age) from Mozambique, Burkina Faso, The Gambia, DR-Congo and Tanzania. Primary efficacy endpoint was the PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at day 28. Analysis was performed for the Intention-To-Treat (ITT) and Per-Protocol (PP) populations.Two-hundred and one patients received the Dispersible Tablet formulation and 99 the conventional one administered as crushed Tablets. At day 28, the PCR-corrected ACPR was 86.9% (ITT) and 98.3% (PP) in the Dispersible Tablet group, and 84.9% (ITT) and 100% (PP) in the crushed Tablet group. At day 42, it was 85.9% (ITT) and 96.5% (PP) in the Dispersible Tablet group, and 82.8% (ITT) and 96.4% (PP) in the crushed Tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (p=0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of Adverse Events and was consistent with that expected in African infants with malaria.A standard three-day treatment with the new Dispersible DHA/PQP formulation is as efficacious as the currently used Tablet in African infants, and has a comparable safety profile

Charles P Larson - One of the best experts on this subject based on the ideXlab platform.

  • Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial
    BMC, 2018
    Co-Authors: Ryan K. Wessells, Charles P Larson, Kenneth H. Brown, Sengchanh Kounnavong, Maxwell A. Barffour, Guy-marino Hinnouho, Somphou Sayasone, Charles B. Stephensen, Kethmany Ratsavong, Charles D. Arnold
    Abstract:

    Abstract Background Zinc is an essential nutrient that is required for children’s normal growth and resistance to infections, including diarrhea and pneumonia, two major causes of child mortality. Daily or weekly preventive zinc supplementation has been shown to improve growth and reduce the risk of infection, while therapeutic zinc supplementation for 10–14 days is recommended for the treatment of diarrhea. The overall objective of the present study is to compare several regimens for delivering zinc to young children, both for the prevention of zinc deficiency and the treatment of diarrhea. Methods The present study is a community-based, randomized controlled trial in the Lao People’s Democratic Republic (PDR). Three thousand, four hundred children 6–23 months of age will be randomized to one of four intervention groups (daily preventive zinc Dispersible Tablet, daily preventive multiple micronutrient powder, therapeutic zinc Dispersible Tablet for diarrhea, or placebo control); interventions will be delivered for 9 months and outcomes measured at pre-determined intervals. Primary outcomes include physical growth (length and weight), diarrhea incidence, hemoglobin and micronutrient status, and innate and adaptive immune function. Secondary outcomes include mid-upper-arm circumference, neuro-behavioral development, hair cortisol concentrations, markers of intestinal inflammation and parasite burden. Incidence of adverse events and the modifying effects of inherited hemoglobin disorders and iron status on the response to the intervention will also be examined. We will estimate unadjusted effects and effects adjusted for selected baseline covariates using ANCOVA. Discussion Many countries are now rolling out large-scale programs to include therapeutic zinc supplementation in the treatment of childhood diarrhea, but few have established programs demonstrated to be effective in the prevention of zinc deficiency. This study will address how best to deliver supplemental zinc to prevent zinc deficiency and reduce the severity of diarrhea-related health complications. Trial registration Trial registration identifier (NCT02428647) ; Date of registration: April 29, 2015

  • development and validation of weight height and age bands to guide the prescription of fixed dose Dispersible Tablet formulations
    The journal of pediatric pharmacology and therapeutics : JPPT, 2015
    Co-Authors: Charles P Larson, Laura Sauve, Jude Kimbowa Senkungu, Shams El Arifeen, Rollin Brant
    Abstract:

    OBJECTIVES: Conversion of pediatric essential drugs from syrup to Dispersible Tablet formulations would require fixed dose options guided by the weight band in which a child falls or a proxy for weight, such as height or age. The purpose of this study was to determine whether weight, height, or age bands can be created that would lead to greater than 95% of children receiving a therapeutic dose of 6 commonly prescribed essential drugs, including paracetamol, iron sulfate, amoxicillin, co-trimoxazole (i.e., trimethoprim/sulfamethoxazole), ciprofloxacin, and co-artemether (i.e., artemether/lumefantrine). METHODS: Using World Health Organization growth standards, we created 4 weight bands and then matched them to height and age 50th percentile growth curves. The resulting weight, height, and age bands were then applied to Ugandan and Bangladeshi anthropometric data sets, and the percentage of children who would have received a correct therapeutic dose based upon weight, height, or age was determined. This pe...

  • development and validation of weight height and age bands to guide the prescription of fixed dose Dispersible Tablet formulations
    The journal of pediatric pharmacology and therapeutics : JPPT, 2015
    Co-Authors: Charles P Larson, Laura Sauve, Jude Kimbowa Senkungu, Shams El Arifeen, Rollin Brant
    Abstract:

    OBJECTIVES: Conversion of pediatric essential drugs from syrup to Dispersible Tablet formulations would require fixed dose options guided by the weight band in which a child falls or a proxy for weight, such as height or age. The purpose of this study was to determine whether weight, height, or age bands can be created that would lead to greater than 95% of children receiving a therapeutic dose of 6 commonly prescribed essential drugs, including paracetamol, iron sulfate, amoxicillin, co-trimoxazole (i.e., trimethoprim/sulfamethoxazole), ciprofloxacin, and co-artemether (i.e., artemether/lumefantrine). METHODS: Using World Health Organization growth standards, we created 4 weight bands and then matched them to height and age 50th percentile growth curves. The resulting weight, height, and age bands were then applied to Ugandan and Bangladeshi anthropometric data sets, and the percentage of children who would have received a correct therapeutic dose based upon weight, height, or age was determined. This pe...

Charles D. Arnold - One of the best experts on this subject based on the ideXlab platform.

  • Plasma and Nail Zinc Concentrations, But Not Hair Zinc, Respond Positively to Two Different Forms of Preventive Zinc Supplementation in Young Laotian Children: a Randomized Controlled Trial
    Biological Trace Element Research, 2020
    Co-Authors: K. Ryan Wessells, Kenneth H. Brown, Sengchanh Kounnavong, Maxwell A. Barffour, Guy-marino Hinnouho, Charles D. Arnold, David W. Killilea, Sonja Y. Hess
    Abstract:

    Plasma zinc concentrations (PZC) have been shown to significantly increase during zinc supplementation. This study investigated the effects of daily preventive zinc supplementation on hair and nail zinc concentrations compared with a control group. In a randomized controlled trial, 6- to 23-month-old children ( n  = 3407) in Lao PDR were randomly assigned to one of four groups and followed for ~ 36 weeks: daily preventive zinc Dispersible Tablet (7 mg/d; PZ), daily micronutrient powder (10 mg zinc/d; MNP), therapeutic zinc supplements for diarrhea treatment (20 mg/d for 10 days; TZ), or daily placebo powder (Control). Plasma, hair, and nail zinc concentrations were assessed in a sub-sample of participants ( n  = 457) at baseline and endline. At baseline, 75% of children had low PZC (

  • Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial
    BMC, 2018
    Co-Authors: Ryan K. Wessells, Charles P Larson, Kenneth H. Brown, Sengchanh Kounnavong, Maxwell A. Barffour, Guy-marino Hinnouho, Somphou Sayasone, Charles B. Stephensen, Kethmany Ratsavong, Charles D. Arnold
    Abstract:

    Abstract Background Zinc is an essential nutrient that is required for children’s normal growth and resistance to infections, including diarrhea and pneumonia, two major causes of child mortality. Daily or weekly preventive zinc supplementation has been shown to improve growth and reduce the risk of infection, while therapeutic zinc supplementation for 10–14 days is recommended for the treatment of diarrhea. The overall objective of the present study is to compare several regimens for delivering zinc to young children, both for the prevention of zinc deficiency and the treatment of diarrhea. Methods The present study is a community-based, randomized controlled trial in the Lao People’s Democratic Republic (PDR). Three thousand, four hundred children 6–23 months of age will be randomized to one of four intervention groups (daily preventive zinc Dispersible Tablet, daily preventive multiple micronutrient powder, therapeutic zinc Dispersible Tablet for diarrhea, or placebo control); interventions will be delivered for 9 months and outcomes measured at pre-determined intervals. Primary outcomes include physical growth (length and weight), diarrhea incidence, hemoglobin and micronutrient status, and innate and adaptive immune function. Secondary outcomes include mid-upper-arm circumference, neuro-behavioral development, hair cortisol concentrations, markers of intestinal inflammation and parasite burden. Incidence of adverse events and the modifying effects of inherited hemoglobin disorders and iron status on the response to the intervention will also be examined. We will estimate unadjusted effects and effects adjusted for selected baseline covariates using ANCOVA. Discussion Many countries are now rolling out large-scale programs to include therapeutic zinc supplementation in the treatment of childhood diarrhea, but few have established programs demonstrated to be effective in the prevention of zinc deficiency. This study will address how best to deliver supplemental zinc to prevent zinc deficiency and reduce the severity of diarrhea-related health complications. Trial registration Trial registration identifier (NCT02428647) ; Date of registration: April 29, 2015

Halidou Tinto - One of the best experts on this subject based on the ideXlab platform.

  • Efficacy and Tolerability Outcomes of a Phase II, Randomized, Open-Label, Multicenter Study of a New Water-Dispersible Pediatric Formulation of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in African
    'American Society for Microbiology', 2018
    Co-Authors: Gargano Nicola, Madrid Lola, Valentini Giovanni, Halidou Tinto, Sirima Sodiomon, Tshefu Antoinette, Gesase Samwel, D'alessandro Umberto, Mtoro Ali, Bassat Orellana Quique
    Abstract:

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new Dispersible-Tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed Tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania. Primary efficacy endpoint was the PCR-corrected adequate clinical and parasitological response (ACPR) at day 28. Analysis was performed for the intention-to-treat (ITT) and per-protocol (PP) populations. A total of 201 patients received the Dispersible-Tablet formulation, and 99 received the conventional one administered as crushed Tablets. At day 28, the PCR-corrected ACPRs were 86.9% (ITT) and 98.3% (PP) in the Dispersible-Tablet group and 84.9% (ITT) and 100% (PP) in the crushed-Tablet group. At day 42, these values were 85.9% (ITT) and 96.5% (PP) in the Dispersible-Tablet group and 82.8% (ITT) and 96.4% (PP) in the crushed-Tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (P = 0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of adverse events and was consistent with that expected in African infants with malaria. A standard 3-day treatment with the new Dispersible DHA/PQP formulation is as efficacious as the currently used Tablet in African infants and has a comparable safety profile.Sin financiación4.715 JCR (2018) Q1, 28/133 Microbiology, 27/267 Pharmacology & Pharmacy2.096 SJR (2018) Q1, 29/298 Infectious Diseases, 11/268 Pharmacology (medical), 21/335 PharmacologyNo data IDR 2018UE

  • A new water-Dispersible paediatric formulation of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in African infants: efficacy and tolerability outcome
    'American Society for Microbiology', 2017
    Co-Authors: Gargano Nicola, Madrid Lola, Valentini Giovanni, Alessandro, Umberto D', Halidou Tinto, Sirima Sodiomon, Tshefu Antoinette, Mtoro, Ali Takadir, Gesase Samwel, Bassat Orellana Quique
    Abstract:

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but paediatric friendly formulations for the treatments of infants are scarce. We aimed to evaluate the efficacy and safety of a new Dispersible Tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed Tablet (Eurartesim(R)) in the treatment of infants with uncomplicated P. falciparum malaria.Reported here are the results of a large phase II, randomized, open label, multicenter trial conducted in African infants (6-12 months of age) from Mozambique, Burkina Faso, The Gambia, DR-Congo and Tanzania. Primary efficacy endpoint was the PCR-corrected Adequate Clinical and Parasitological Response (ACPR) at day 28. Analysis was performed for the Intention-To-Treat (ITT) and Per-Protocol (PP) populations.Two-hundred and one patients received the Dispersible Tablet formulation and 99 the conventional one administered as crushed Tablets. At day 28, the PCR-corrected ACPR was 86.9% (ITT) and 98.3% (PP) in the Dispersible Tablet group, and 84.9% (ITT) and 100% (PP) in the crushed Tablet group. At day 42, it was 85.9% (ITT) and 96.5% (PP) in the Dispersible Tablet group, and 82.8% (ITT) and 96.4% (PP) in the crushed Tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences (p=0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of Adverse Events and was consistent with that expected in African infants with malaria.A standard three-day treatment with the new Dispersible DHA/PQP formulation is as efficacious as the currently used Tablet in African infants, and has a comparable safety profile