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Gerardo Priotto - One of the best experts on this subject based on the ideXlab platform.

  • Nifurtimox eflornithine combination therapy for second stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in congo
    Clinical Infectious Diseases, 2007
    Co-Authors: Gerardo Priotto, D Ngouama, Sara Ghorashian, U Arnold, Salah Ghabri, Susan Kasparian, Unni Karunakara
    Abstract:

    Background. Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the Nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second- stage disease. Methods. A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus Nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. Results. A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the Nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the Nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the Nifurtimox-eflornithine arm. Conclusions. The Nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new Nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies. Human African trypanosomiasis (HAT), or sleeping sickness, remains a public health challenge in sub-Saharan Africa, with an estimated 50,000-70,000 new cases per year, of which ∼20,000 are detected and reported (1). The disease is caused by the protozoan parasite Trypanosoma brucei gambiense, which is transmitted by the tsetse fly (Glossina species), and it pro- gresses from the hemolymphatic first stage to the meningo- encephalitic second stage. It is invariably fatal without appro- priate treatment. Since 1949, melarsoprol is the most commonly used treatment for second-stage HAT. This arsenical derivative is associated with severe toxic effects—in particular, reactive encephalopathy, which is fatal in 10%-70% of cases and affects 5%-10% of treated patients (2, 3). Moreover, in-

  • Nifurtimox plus eflornithine for late stage sleeping sickness in uganda a case series
    PLOS Neglected Tropical Diseases, 2007
    Co-Authors: Francesco Checchi, Patrice Piola, Harriet Ayikoru, Florence Thomas, Dominique Legros, Gerardo Priotto
    Abstract:

    Background We report efficacy and safety outcomes from a prospective case series of 31 late-stage T.b. gambiense sleeping sickness (Human African Trypanosomiasis, HAT) patients treated with a combination of Nifurtimox and eflornithine (N+E) in Yumbe, northwest Uganda in 2002–2003, following on a previously reported terminated trial in nearby Omugo, in which 17 patients received the combination under the same conditions.

  • three drug combinations for late stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in uganda
    PLOS Clinical Trials, 2006
    Co-Authors: Gerardo Priotto, Salah Ghabri, Manica Balasegaram, Francesco Checchi, Carole Fogg, Olema Erphas, Albino Louga, Patrice Piola
    Abstract:

    Objectives Our objective was to compare the efficacy and safety of three drug combinations for the treatment of late-stage human African trypanosomiasis caused by Trypanosoma brucei gambiense. Design This trial was a randomized, open-label, active control, parallel clinical trial comparing three arms. Setting The study took place at the Sleeping Sickness Treatment Center run by Medecins Sans Frontieres at Omugo, Arua District, Uganda Participants Stage 2 patients diagnosed in Northern Uganda were screened for inclusion and a total of 54 selected. Interventions Three drug combinations were given to randomly assigned patients: melarsoprol-Nifurtimox (M+N), melarsoprol-eflornithine (M+E), and Nifurtimox-eflornithine (N+E). Dosages were uniform: intravenous (IV) melarsoprol 1.8 mg/kg/d, daily for 10 d; IV eflornithine 400 mg/kg/d, every 6 h for 7 d; oral Nifurtimox 15 (adults) or 20 (children <15 y) mg/kg/d, every 8 h for 10 d. Patients were followed up for 24 mo. Outcome Measures Outcomes were cure rates and adverse events attributable to treatment. Results Randomization was performed on 54 patients before enrollment was suspended due to unacceptable toxicity in one of the three arms. Cure rates obtained with the intention to treat analysis were M+N 44.4%, M+E 78.9%, and N+E 94.1%, and were significantly higher with N+E (p = 0.003) and M+E (p = 0.045) than with M+N. Adverse events were less frequent and less severe with N+E, resulting in fewer treatment interruptions and no fatalities. Four patients died who were taking melarsoprol-Nifurtimox and one who was taking melarsoprol-eflornithine. Conclusions The N+E combination appears to be a promising first-line therapy that may improve treatment of sleeping sickness, although the results from this interrupted study do not permit conclusive interpretations. Larger studies are needed to continue the evaluation of this drug combination in the treatment of T. b. gambiense sleeping sickness. Trial Registration ClinicalTrials.gov NCT00330148

Patrice Piola - One of the best experts on this subject based on the ideXlab platform.

  • Nifurtimox plus eflornithine for late stage sleeping sickness in uganda a case series
    PLOS Neglected Tropical Diseases, 2007
    Co-Authors: Francesco Checchi, Patrice Piola, Harriet Ayikoru, Florence Thomas, Dominique Legros, Gerardo Priotto
    Abstract:

    Background We report efficacy and safety outcomes from a prospective case series of 31 late-stage T.b. gambiense sleeping sickness (Human African Trypanosomiasis, HAT) patients treated with a combination of Nifurtimox and eflornithine (N+E) in Yumbe, northwest Uganda in 2002–2003, following on a previously reported terminated trial in nearby Omugo, in which 17 patients received the combination under the same conditions.

  • three drug combinations for late stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in uganda
    PLOS Clinical Trials, 2006
    Co-Authors: Gerardo Priotto, Salah Ghabri, Manica Balasegaram, Francesco Checchi, Carole Fogg, Olema Erphas, Albino Louga, Patrice Piola
    Abstract:

    Objectives Our objective was to compare the efficacy and safety of three drug combinations for the treatment of late-stage human African trypanosomiasis caused by Trypanosoma brucei gambiense. Design This trial was a randomized, open-label, active control, parallel clinical trial comparing three arms. Setting The study took place at the Sleeping Sickness Treatment Center run by Medecins Sans Frontieres at Omugo, Arua District, Uganda Participants Stage 2 patients diagnosed in Northern Uganda were screened for inclusion and a total of 54 selected. Interventions Three drug combinations were given to randomly assigned patients: melarsoprol-Nifurtimox (M+N), melarsoprol-eflornithine (M+E), and Nifurtimox-eflornithine (N+E). Dosages were uniform: intravenous (IV) melarsoprol 1.8 mg/kg/d, daily for 10 d; IV eflornithine 400 mg/kg/d, every 6 h for 7 d; oral Nifurtimox 15 (adults) or 20 (children <15 y) mg/kg/d, every 8 h for 10 d. Patients were followed up for 24 mo. Outcome Measures Outcomes were cure rates and adverse events attributable to treatment. Results Randomization was performed on 54 patients before enrollment was suspended due to unacceptable toxicity in one of the three arms. Cure rates obtained with the intention to treat analysis were M+N 44.4%, M+E 78.9%, and N+E 94.1%, and were significantly higher with N+E (p = 0.003) and M+E (p = 0.045) than with M+N. Adverse events were less frequent and less severe with N+E, resulting in fewer treatment interruptions and no fatalities. Four patients died who were taking melarsoprol-Nifurtimox and one who was taking melarsoprol-eflornithine. Conclusions The N+E combination appears to be a promising first-line therapy that may improve treatment of sleeping sickness, although the results from this interrupted study do not permit conclusive interpretations. Larger studies are needed to continue the evaluation of this drug combination in the treatment of T. b. gambiense sleeping sickness. Trial Registration ClinicalTrials.gov NCT00330148

Salah Ghabri - One of the best experts on this subject based on the ideXlab platform.

  • Nifurtimox eflornithine combination therapy for second stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in congo
    Clinical Infectious Diseases, 2007
    Co-Authors: Gerardo Priotto, D Ngouama, Sara Ghorashian, U Arnold, Salah Ghabri, Susan Kasparian, Unni Karunakara
    Abstract:

    Background. Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the Nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second- stage disease. Methods. A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus Nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. Results. A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the Nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the Nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the Nifurtimox-eflornithine arm. Conclusions. The Nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new Nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies. Human African trypanosomiasis (HAT), or sleeping sickness, remains a public health challenge in sub-Saharan Africa, with an estimated 50,000-70,000 new cases per year, of which ∼20,000 are detected and reported (1). The disease is caused by the protozoan parasite Trypanosoma brucei gambiense, which is transmitted by the tsetse fly (Glossina species), and it pro- gresses from the hemolymphatic first stage to the meningo- encephalitic second stage. It is invariably fatal without appro- priate treatment. Since 1949, melarsoprol is the most commonly used treatment for second-stage HAT. This arsenical derivative is associated with severe toxic effects—in particular, reactive encephalopathy, which is fatal in 10%-70% of cases and affects 5%-10% of treated patients (2, 3). Moreover, in-

  • three drug combinations for late stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in uganda
    PLOS Clinical Trials, 2006
    Co-Authors: Gerardo Priotto, Salah Ghabri, Manica Balasegaram, Francesco Checchi, Carole Fogg, Olema Erphas, Albino Louga, Patrice Piola
    Abstract:

    Objectives Our objective was to compare the efficacy and safety of three drug combinations for the treatment of late-stage human African trypanosomiasis caused by Trypanosoma brucei gambiense. Design This trial was a randomized, open-label, active control, parallel clinical trial comparing three arms. Setting The study took place at the Sleeping Sickness Treatment Center run by Medecins Sans Frontieres at Omugo, Arua District, Uganda Participants Stage 2 patients diagnosed in Northern Uganda were screened for inclusion and a total of 54 selected. Interventions Three drug combinations were given to randomly assigned patients: melarsoprol-Nifurtimox (M+N), melarsoprol-eflornithine (M+E), and Nifurtimox-eflornithine (N+E). Dosages were uniform: intravenous (IV) melarsoprol 1.8 mg/kg/d, daily for 10 d; IV eflornithine 400 mg/kg/d, every 6 h for 7 d; oral Nifurtimox 15 (adults) or 20 (children <15 y) mg/kg/d, every 8 h for 10 d. Patients were followed up for 24 mo. Outcome Measures Outcomes were cure rates and adverse events attributable to treatment. Results Randomization was performed on 54 patients before enrollment was suspended due to unacceptable toxicity in one of the three arms. Cure rates obtained with the intention to treat analysis were M+N 44.4%, M+E 78.9%, and N+E 94.1%, and were significantly higher with N+E (p = 0.003) and M+E (p = 0.045) than with M+N. Adverse events were less frequent and less severe with N+E, resulting in fewer treatment interruptions and no fatalities. Four patients died who were taking melarsoprol-Nifurtimox and one who was taking melarsoprol-eflornithine. Conclusions The N+E combination appears to be a promising first-line therapy that may improve treatment of sleeping sickness, although the results from this interrupted study do not permit conclusive interpretations. Larger studies are needed to continue the evaluation of this drug combination in the treatment of T. b. gambiense sleeping sickness. Trial Registration ClinicalTrials.gov NCT00330148

Francesco Checchi - One of the best experts on this subject based on the ideXlab platform.

  • Nifurtimox plus eflornithine for late stage sleeping sickness in uganda a case series
    PLOS Neglected Tropical Diseases, 2007
    Co-Authors: Francesco Checchi, Patrice Piola, Harriet Ayikoru, Florence Thomas, Dominique Legros, Gerardo Priotto
    Abstract:

    Background We report efficacy and safety outcomes from a prospective case series of 31 late-stage T.b. gambiense sleeping sickness (Human African Trypanosomiasis, HAT) patients treated with a combination of Nifurtimox and eflornithine (N+E) in Yumbe, northwest Uganda in 2002–2003, following on a previously reported terminated trial in nearby Omugo, in which 17 patients received the combination under the same conditions.

  • three drug combinations for late stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in uganda
    PLOS Clinical Trials, 2006
    Co-Authors: Gerardo Priotto, Salah Ghabri, Manica Balasegaram, Francesco Checchi, Carole Fogg, Olema Erphas, Albino Louga, Patrice Piola
    Abstract:

    Objectives Our objective was to compare the efficacy and safety of three drug combinations for the treatment of late-stage human African trypanosomiasis caused by Trypanosoma brucei gambiense. Design This trial was a randomized, open-label, active control, parallel clinical trial comparing three arms. Setting The study took place at the Sleeping Sickness Treatment Center run by Medecins Sans Frontieres at Omugo, Arua District, Uganda Participants Stage 2 patients diagnosed in Northern Uganda were screened for inclusion and a total of 54 selected. Interventions Three drug combinations were given to randomly assigned patients: melarsoprol-Nifurtimox (M+N), melarsoprol-eflornithine (M+E), and Nifurtimox-eflornithine (N+E). Dosages were uniform: intravenous (IV) melarsoprol 1.8 mg/kg/d, daily for 10 d; IV eflornithine 400 mg/kg/d, every 6 h for 7 d; oral Nifurtimox 15 (adults) or 20 (children <15 y) mg/kg/d, every 8 h for 10 d. Patients were followed up for 24 mo. Outcome Measures Outcomes were cure rates and adverse events attributable to treatment. Results Randomization was performed on 54 patients before enrollment was suspended due to unacceptable toxicity in one of the three arms. Cure rates obtained with the intention to treat analysis were M+N 44.4%, M+E 78.9%, and N+E 94.1%, and were significantly higher with N+E (p = 0.003) and M+E (p = 0.045) than with M+N. Adverse events were less frequent and less severe with N+E, resulting in fewer treatment interruptions and no fatalities. Four patients died who were taking melarsoprol-Nifurtimox and one who was taking melarsoprol-eflornithine. Conclusions The N+E combination appears to be a promising first-line therapy that may improve treatment of sleeping sickness, although the results from this interrupted study do not permit conclusive interpretations. Larger studies are needed to continue the evaluation of this drug combination in the treatment of T. b. gambiense sleeping sickness. Trial Registration ClinicalTrials.gov NCT00330148

Unni Karunakara - One of the best experts on this subject based on the ideXlab platform.

  • Nifurtimox eflornithine combination therapy for second stage trypanosoma brucei gambiense sleeping sickness a randomized clinical trial in congo
    Clinical Infectious Diseases, 2007
    Co-Authors: Gerardo Priotto, D Ngouama, Sara Ghorashian, U Arnold, Salah Ghabri, Susan Kasparian, Unni Karunakara
    Abstract:

    Background. Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the Nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second- stage disease. Methods. A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus Nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. Results. A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the Nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the Nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the Nifurtimox-eflornithine arm. Conclusions. The Nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new Nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies. Human African trypanosomiasis (HAT), or sleeping sickness, remains a public health challenge in sub-Saharan Africa, with an estimated 50,000-70,000 new cases per year, of which ∼20,000 are detected and reported (1). The disease is caused by the protozoan parasite Trypanosoma brucei gambiense, which is transmitted by the tsetse fly (Glossina species), and it pro- gresses from the hemolymphatic first stage to the meningo- encephalitic second stage. It is invariably fatal without appro- priate treatment. Since 1949, melarsoprol is the most commonly used treatment for second-stage HAT. This arsenical derivative is associated with severe toxic effects—in particular, reactive encephalopathy, which is fatal in 10%-70% of cases and affects 5%-10% of treated patients (2, 3). Moreover, in-