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Oriol Mitja - One of the best experts on this subject based on the ideXlab platform.
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single dose azithromycin versus Benzathine benzylpenicillin for treatment of yaws in children in papua new guinea an open label non inferiority randomised trial
The Lancet, 2012Co-Authors: Russell Hays, Anthony Ipai, Moses Penias, Raymond Paru, David Fagaho, Elisa De Lazzari, Oriol Mitja, Quique BassatAbstract:Summary Background Yaws—an endemic treponematosis and, as such, a neglected tropical disease—is re-emerging in children in rural, tropical areas. Oral azithromycin is effective for syphilis. We assessed the efficacy of azithromycin compared with intramuscular long-acting penicillin to treat patients with yaws. Methods We did an open-label, non-inferiority, randomised trial at Lihir Medical Centre, Papua New Guinea, between Sept 1, 2010, and Feb 1, 2011. Children aged 6 months to 15 years with a serologically confirmed diagnosis of yaws were randomly allocated, by a computer-generated randomisation sequence, to receive either one 30 mg/kg oral dose of azithromycin or an intramuscular injection of 50 000 units per kg Benzathine benzylpenicillin. Investigators were masked to group assignment. The primary endpoint was treatment efficacy, with cure rate defined serologically as a decrease in rapid plasma reagin titre of at least two dilutions by 6 months after treatment, and, in participants with primary ulcers, also by epithelialisation of lesions within 2 weeks. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10%. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01382004. Findings We allocated 124 patients to the azithromycin group and 126 to the Benzathine benzylpenicillin group. In the per-protocol analysis, after 6 months of follow-up, 106 (96%) of 110 patients in the azithromycin group were cured, compared with 105 (93%) of 113 in the Benzathine benzylpenicillin group (treatment difference −3·4%; 95% CI −9·3 to 2·4), thus meeting prespecified criteria for non-inferiority. The number of drug-related adverse events (all mild or moderate) was similar in both treatment groups (ten [8%] in the azithromycin group vs eight [7%] in the Benzathine benzylpenicillin group). Interpretation A single oral dose of azithromycin is non-inferior to Benzathine benzylpenicillin and avoids the need for injection equipment and medically trained personnel. A change to the simpler azithromycin treatment regimen could enable yaws elimination through mass drug administration programmes. Funding International SOS and Newcrest Mining.
Fred Binka - One of the best experts on this subject based on the ideXlab platform.
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a single dose oral azithromycin versus intramuscular Benzathine penicillin for the treatment of yaws a randomized non inferiority trial in ghana
PLOS Neglected Tropical Diseases, 2017Co-Authors: Cynthia Kwakyemaclean, Nsiire Agana, Priscilia Nortey, Esther Aryee, Kingsley Asiedu, Roland Ballard, John O Gyapong, Yaw Adusarkodie, Fred BinkaAbstract:Background Yaws is a treponemal infection that was almost eradicated fifty years ago; however, the disease has re-emerged in a number of countries including Ghana. A single-dose of intramuscular Benzathine penicillin has been the mainstay of treatment for yaws. However, intramuscular injections are painful and pose safety and logistical constraints in the poor areas where yaws occurs. A single center randomized control trial (RCT) carried out in Papua New Guinea in 2012 demonstrated the efficacy of a single-dose of oral azithromycin for the treatment of yaws. In this study, we also compared the efficacy of a single oral dose of azithromycin as an alternative to intramuscular Benzathine penicillin for the treatment of the disease in another geographic setting. Methodology We conducted an open-label, randomized non-inferiority trial in three neighboring yaws-endemic districts in Southern Ghana. Children aged 1–15 years with yaws lesions were assigned to receive either 30mg/kg of oral azithromycin or 50,000 units/kg of intramuscular Benzathine penicillin. The primary end point was clinical cure rate, defined as a complete or partial resolution of lesions 3 weeks after treatment. The secondary endpoint was serological cure, defined as at least a 4-fold decline in baseline RPR titre 6 months after treatment. Non- inferiority of azithromycin treatment was determined if the upper bound limit of a 2 sided 95% CI was less than 10%. Findings The mean age of participants was 9.5 years (S.D.3.1, range: 1–15 years), 247(70%) were males. The clinical cure rates were 98.2% (95% CI: 96.2–100) in the azithromycin group and 96.9% (95% CI: 94.1–99.6) in the Benzathine penicillin group. The serological cure rates at 6 months were 57.4% (95% CI: 49.9–64.9) in the azithromycin group and 49.1% (95% CI: 41.2–56.9) in the Benzathine penicillin group, thus achieving the specified criteria for non-inferiority. Conclusions A single oral dose of azithromycin, at a dosage of 30mg/kg, was non-inferior to a single dose of intramuscular Benzathine penicillin for the treatment of early yaws among Ghanaian patients, and provides additional support for the WHO policy for use of oral azithromycin for the eradication of yaws in resource-poor settings. Trial Registration Pan African Clinical Trials Registry PACTR2013030005181 http://www.pactr.org/
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Before and After Treatment with Benzathine penicillin Papillomatous ulcer on the neck of patient showing complete healing after 3 weeks of treatment with Benzathine penicillin: A. Before Treatment, B. After Treatment.
2017Co-Authors: Cynthia Kwakye-maclean, Nsiire Agana, John Gyapong, Priscilia Nortey, Yaw Adu-sarkodie, Esther Aryee, Kingsley Asiedu, Roland Ballard, Fred BinkaAbstract:Before and After Treatment with Benzathine penicillin Papillomatous ulcer on the neck of patient showing complete healing after 3 weeks of treatment with Benzathine penicillin: A. Before Treatment, B. After Treatment.
Quique Bassat - One of the best experts on this subject based on the ideXlab platform.
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single dose azithromycin versus Benzathine benzylpenicillin for treatment of yaws in children in papua new guinea an open label non inferiority randomised trial
The Lancet, 2012Co-Authors: Russell Hays, Anthony Ipai, Moses Penias, Raymond Paru, David Fagaho, Elisa De Lazzari, Oriol Mitja, Quique BassatAbstract:Summary Background Yaws—an endemic treponematosis and, as such, a neglected tropical disease—is re-emerging in children in rural, tropical areas. Oral azithromycin is effective for syphilis. We assessed the efficacy of azithromycin compared with intramuscular long-acting penicillin to treat patients with yaws. Methods We did an open-label, non-inferiority, randomised trial at Lihir Medical Centre, Papua New Guinea, between Sept 1, 2010, and Feb 1, 2011. Children aged 6 months to 15 years with a serologically confirmed diagnosis of yaws were randomly allocated, by a computer-generated randomisation sequence, to receive either one 30 mg/kg oral dose of azithromycin or an intramuscular injection of 50 000 units per kg Benzathine benzylpenicillin. Investigators were masked to group assignment. The primary endpoint was treatment efficacy, with cure rate defined serologically as a decrease in rapid plasma reagin titre of at least two dilutions by 6 months after treatment, and, in participants with primary ulcers, also by epithelialisation of lesions within 2 weeks. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10%. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01382004. Findings We allocated 124 patients to the azithromycin group and 126 to the Benzathine benzylpenicillin group. In the per-protocol analysis, after 6 months of follow-up, 106 (96%) of 110 patients in the azithromycin group were cured, compared with 105 (93%) of 113 in the Benzathine benzylpenicillin group (treatment difference −3·4%; 95% CI −9·3 to 2·4), thus meeting prespecified criteria for non-inferiority. The number of drug-related adverse events (all mild or moderate) was similar in both treatment groups (ten [8%] in the azithromycin group vs eight [7%] in the Benzathine benzylpenicillin group). Interpretation A single oral dose of azithromycin is non-inferior to Benzathine benzylpenicillin and avoids the need for injection equipment and medically trained personnel. A change to the simpler azithromycin treatment regimen could enable yaws elimination through mass drug administration programmes. Funding International SOS and Newcrest Mining.
Cynthia Kwakyemaclean - One of the best experts on this subject based on the ideXlab platform.
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a single dose oral azithromycin versus intramuscular Benzathine penicillin for the treatment of yaws a randomized non inferiority trial in ghana
PLOS Neglected Tropical Diseases, 2017Co-Authors: Cynthia Kwakyemaclean, Nsiire Agana, Priscilia Nortey, Esther Aryee, Kingsley Asiedu, Roland Ballard, John O Gyapong, Yaw Adusarkodie, Fred BinkaAbstract:Background Yaws is a treponemal infection that was almost eradicated fifty years ago; however, the disease has re-emerged in a number of countries including Ghana. A single-dose of intramuscular Benzathine penicillin has been the mainstay of treatment for yaws. However, intramuscular injections are painful and pose safety and logistical constraints in the poor areas where yaws occurs. A single center randomized control trial (RCT) carried out in Papua New Guinea in 2012 demonstrated the efficacy of a single-dose of oral azithromycin for the treatment of yaws. In this study, we also compared the efficacy of a single oral dose of azithromycin as an alternative to intramuscular Benzathine penicillin for the treatment of the disease in another geographic setting. Methodology We conducted an open-label, randomized non-inferiority trial in three neighboring yaws-endemic districts in Southern Ghana. Children aged 1–15 years with yaws lesions were assigned to receive either 30mg/kg of oral azithromycin or 50,000 units/kg of intramuscular Benzathine penicillin. The primary end point was clinical cure rate, defined as a complete or partial resolution of lesions 3 weeks after treatment. The secondary endpoint was serological cure, defined as at least a 4-fold decline in baseline RPR titre 6 months after treatment. Non- inferiority of azithromycin treatment was determined if the upper bound limit of a 2 sided 95% CI was less than 10%. Findings The mean age of participants was 9.5 years (S.D.3.1, range: 1–15 years), 247(70%) were males. The clinical cure rates were 98.2% (95% CI: 96.2–100) in the azithromycin group and 96.9% (95% CI: 94.1–99.6) in the Benzathine penicillin group. The serological cure rates at 6 months were 57.4% (95% CI: 49.9–64.9) in the azithromycin group and 49.1% (95% CI: 41.2–56.9) in the Benzathine penicillin group, thus achieving the specified criteria for non-inferiority. Conclusions A single oral dose of azithromycin, at a dosage of 30mg/kg, was non-inferior to a single dose of intramuscular Benzathine penicillin for the treatment of early yaws among Ghanaian patients, and provides additional support for the WHO policy for use of oral azithromycin for the eradication of yaws in resource-poor settings. Trial Registration Pan African Clinical Trials Registry PACTR2013030005181 http://www.pactr.org/
Jonathan R Carapetis - One of the best experts on this subject based on the ideXlab platform.
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subcutaneous administration of Benzathine benzylpenicillin g has favourable pharmacokinetic characteristics for the prevention of rheumatic heart disease compared with intramuscular injection a randomized crossover population pharmacokinetic study in
Journal of Antimicrobial Chemotherapy, 2020Co-Authors: Joseph Kado, Jonathan R Carapetis, Sam Salman, Robert Henderson, Robert Hand, Rosemary Wyber, Madhu Pagesharp, Kevin T Batty, Laurens ManningAbstract:BACKGROUND Benzathine penicillin G has been used as monthly deep intramuscular (IM) injections since the 1950s for secondary prevention of acute rheumatic fever and rheumatic heart disease (RHD). Injection frequency and pain are major programmatic barriers for adherence, prompting calls for development of better long-acting penicillin preparations to prevent RHD. We hypothesized that subcutaneous (SC) administration of Benzathine penicillin G could delay penicillin absorption when compared with IM injections. METHODS To compare the pharmacokinetic profile and tolerability of Benzathine penicillin G according to different routes of administration, 15 healthy males participated in a randomized crossover study to receive Benzathine penicillin G by either SC or IM routes, with a 10 week washout period before the second dose by the alternative route. Ultrasound guidance confirmed injection location. Penicillin concentrations and pain scores were measured for 6 weeks following injections. RESULTS SC administration was well tolerated with no significant differences in pain scores. Following SC injection, the principal absorption half-life (95% CI) was 20.1 (16.3-29.5) days and 89.6% (87.1%-92.0%) of the drug was directed via this pathway compared with 10.2 (8.6-12.5) days and 71.3% (64.9%-77.4%) following IM administration. Lower peak and higher trough penicillin concentrations resulted following SC injection. Simulations demonstrated that SC infusion of higher doses of Benzathine penicillin G could provide therapeutic penicillin concentrations for 3 months. CONCLUSIONS SC administration of Benzathine penicillin G is safe and significantly delays penicillin absorption. High-dose Benzathine penicillin G via the SC route would fulfil many product characteristics required for the next generation of longer-acting penicillins for use in RHD.
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Myositis complicating Benzathine penicillin-G injection in a case of rheumatic heart disease.
IDCases, 2016Co-Authors: Joshua R. Francis, Rosemary Wyber, Bo Remenyi, David Croser, Jonathan R CarapetisAbstract:A 7-year old boy developed myositis secondary to intramuscular injection of Benzathine penicillin-G in the context of secondary prophylaxis for rheumatic heart disease. Side effects of intramuscular delivery of Benzathine penicillin-G are well described and include injection site pain and inflammation, but myositis, as depicted on magnetic resonance imaging in this case, has not previously been described.
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short course oral co trimoxazole versus intramuscular Benzathine benzylpenicillin for impetigo in a highly endemic region an open label randomised controlled non inferiority trial
The Lancet, 2014Co-Authors: Asha C Bowen, Irene M Omeara, Mark D. Chatfield, Ross M Andrews, Steven Y C Tong, Malcolm Mcdonald, Bart J. Currie, Jonathan R CarapetisAbstract:Summary Background Impetigo affects more than 110 million children worldwide at any one time. The major burden of disease is in developing and tropical settings where topical antibiotics are impractical and lead to rapid emergence of antimicrobial resistance. Few trials of systemic antibiotics are available to guide management of extensive impetigo. As such, we aimed to compare short-course oral co-trimoxazole with standard treatment with intramuscular Benzathine benzylpenicillin in children with impetigo in a highly endemic setting. Methods In this randomised, controlled, non-inferiority trial, Indigenous Australian children aged 3 months to 13 years with purulent or crusted non-bullous impetigo were randomly assigned (1:1:1) to receive Benzathine benzylpenicillin (weight-banded injection), twice-daily co-trimoxazole for 3 days (4 mg/kg plus 20 mg/kg per dose), or once-daily co-trimoxazole for 5 days (8 mg/kg plus 40 mg/kg per dose). At every visit, participants were randomised in blocks of six and 12, stratified by disease severity. Randomisation was done by research nurses and codes were in sealed, sequentially numbered, opaque envelopes. Independent reviewers masked to treatment allocation compared digital images of sores from days 0 and 7. The primary outcome was treatment success at day 7 in a modified intention-to-treat analysis. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000858291. Findings Between Nov 26, 2009, and Nov 20, 2012, 508 patients were randomly assigned to receive Benzathine benzylpenicillin (n=165 [156 analysed]), twice-daily co-trimoxazole for 3 days (n=175 [173 analysed]), or once-daily co-trimoxazole for 5 days (n=168 [161 analysed]). Treatment was successful in 133 (85%) children who received Benzathine benzylpenicillin and 283 (85%) who received pooled co-trimoxazole (absolute difference 0·5%; 95% CI −6·2 to 7·3), showing non-inferiority of co-trimoxazole (10% margin). Results for twice-daily co-trimoxazole for 3 days and once-daily co-trimoxazole for 5 days were similar. Adverse events occurred in 54 participants, 49 (90%) of whom received Benzathine benzylpenicillin. Interpretation Short-course co-trimoxazole is a non-inferior, alternative treatment to Benzathine benzylpenicillin for impetigo; it is palatable, pain-free, practical, and easily administered. Funding Australian National Health and Medical Research Council.
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Trimethopim-sulfamethoxazole compared with Benzathine penicillin for treatment of impetigo in Aboriginal children: a pilot randomised controlled trial.
Journal of Paediatrics and Child Health, 2010Co-Authors: Steven Y C Tong, Ross M Andrews, Bart J. Currie, Therese M. Kearns, Rosalyn Gundjirryirr, Malcolm I. Mcdonald, Jonathan R CarapetisAbstract:We conducted a pilot randomized controlled trial comparing trimethoprim-sulfamethoxazole to Benzathine penicillin for treatment of impetigo in Aboriginal children. Treatment was successful in 7 of 7 children treated with trimethoprim-sulfamethoxazole and 5 of 6 treated with Benzathine penicillin. Trimethoprim-sulfamethoxazole achieved microbiological clearance and healing of sores from which β-hemolytic streptococci and community-associated methicillin-resistant Staphylococcus aureus were initially cultured.