Journal Article > ResearchFull Text
Malar J. 2013 July 17; Volume 12 (Issue 1); 250.; DOI:10.1186/1475-2875-12-250
Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R, et al.
Malar J. 2013 July 17; Volume 12 (Issue 1); 250.; DOI:10.1186/1475-2875-12-250
BACKGROUND
Safety surveillance of widely used artemisinin-based combination therapy (ACT) is essential, but tolerability data in the over five years age group are largely anecdotal.
METHODS
Two open-label, randomized trials were conducted in Nimba County, Liberia: i) the main tolerability trial with 1,000 Plasmodium falciparum malaria patients aged over five years (Study-T), and, ii) an efficacy trial with a secondary objective of collecting tolerability data among 300 children age six to 59 months (Study-E). In both studies patients were randomized to fixed-dose artesunate-amodiaquine (ASAQ Winthrop®) or artemether-lumefantrine (AL, Coartem®), respectively. Clinical- and laboratory-adverse events (AEs) were recorded until day 28.
RESULTS
Study-T: most patients experienced at least one AE. Severe AEs were few, primarily asymptomatic blood system disorders or increased liver enzyme values. No treatment or study discontinuation occurred. Mild or moderate fatigue (39.8% vs 16.3%, p < 0.001), vomiting (7.1% vs 1.6%, p < 0.001), nausea (3.2% vs 1.0%, p = 0.01), and anaemia (14.9% vs 9.8%, p = 0.01) were more frequently recorded in the ASAQ versus AL arm. Study-E: mild or moderate AEs were common, including anaemia, fatigue, vomiting or diarrhoea. The few severe events were asymptomatic blood system disorders and four clinical events (pneumonia, malaria, vomiting and stomatitis).
CONCLUSION
Both ASAQ and AL were well tolerated in patients of all age groups. No unexpected AEs occurred. Certain mild or moderate AEs were more frequent in the ASAQ arm. Standardised safety surveillance should continue for all forms of ACT.
TRIAL REGISTRATION
The protocols were registered with Current Controlled Trials, under the identifier numbers ISRCTN40020296, ISRCTN51688713, (http://www.controlled-trials.com).
Safety surveillance of widely used artemisinin-based combination therapy (ACT) is essential, but tolerability data in the over five years age group are largely anecdotal.
METHODS
Two open-label, randomized trials were conducted in Nimba County, Liberia: i) the main tolerability trial with 1,000 Plasmodium falciparum malaria patients aged over five years (Study-T), and, ii) an efficacy trial with a secondary objective of collecting tolerability data among 300 children age six to 59 months (Study-E). In both studies patients were randomized to fixed-dose artesunate-amodiaquine (ASAQ Winthrop®) or artemether-lumefantrine (AL, Coartem®), respectively. Clinical- and laboratory-adverse events (AEs) were recorded until day 28.
RESULTS
Study-T: most patients experienced at least one AE. Severe AEs were few, primarily asymptomatic blood system disorders or increased liver enzyme values. No treatment or study discontinuation occurred. Mild or moderate fatigue (39.8% vs 16.3%, p < 0.001), vomiting (7.1% vs 1.6%, p < 0.001), nausea (3.2% vs 1.0%, p = 0.01), and anaemia (14.9% vs 9.8%, p = 0.01) were more frequently recorded in the ASAQ versus AL arm. Study-E: mild or moderate AEs were common, including anaemia, fatigue, vomiting or diarrhoea. The few severe events were asymptomatic blood system disorders and four clinical events (pneumonia, malaria, vomiting and stomatitis).
CONCLUSION
Both ASAQ and AL were well tolerated in patients of all age groups. No unexpected AEs occurred. Certain mild or moderate AEs were more frequent in the ASAQ arm. Standardised safety surveillance should continue for all forms of ACT.
TRIAL REGISTRATION
The protocols were registered with Current Controlled Trials, under the identifier numbers ISRCTN40020296, ISRCTN51688713, (http://www.controlled-trials.com).
Protocol > Research Study
Gartley M, Valeh P, de Lange RFJ, Viscusi A, Lenglet AD, et al.
2013 December 1; Volume 11 (Issue 4); 623-628.; DOI:10.2166/wh.2013.050
Médecins Sans Frontières-Operational Centre Amsterdam piloted the distribution of household disinfection kits (HDKs) and health promotion sessions for cholera prevention in households of patients admitted to their cholera treatment centres in Carrefour, Port au Prince, Haiti, between December 2010 and February 2011. We conducted a follow-up survey with 208 recipient households to determine the uptake and use of the kits and understanding of the health promotion messages. In 61% of surveyed households, a caregiver had been the recipient of the HDK and 57.7% of households had received the HDKs after the discharge of the patient. Among surveyed households, 97.6% stated they had used the contents of the HDK after receiving it, with 75% of these reporting using five or more items, with the two most popular items being chlorine and soap. A significant (p < 0.05) increase in self-reported use items in the HDK was observed in households that received kits after 24 January 2011 when the education messages were strengthened. To our knowledge, this is the first time it has been demonstrated that during a large-scale cholera outbreak, the distribution of simple kits, with readily available cleaning products and materials, combined with health promotion is easy, feasible, and valued by the target population.
Journal Article > ResearchFull Text
Malar J. 2013 July 17; Volume 12 (Issue 1); 251.; DOI:10.1186/1475-2875-12-251
Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R, et al.
Malar J. 2013 July 17; Volume 12 (Issue 1); 251.; DOI:10.1186/1475-2875-12-251
BACKGROUND
Prospective efficacy monitoring of anti-malarial treatments is imperative for timely detection of resistance development. The in vivo efficacy of artesunate-amodiaquine (ASAQ) fixed-dose combination (FDC) was compared to that of artemether-lumefantrine (AL) among children aged six to 59 months in Nimba County, Liberia, where Plasmodium falciparum malaria is endemic and efficacy data are scarce.
METHODS
An open-label, randomized controlled non-inferiority trial compared the genotyping adjusted day 42 cure rates of ASAQ FDC (ASAQ Winthrop®) to AL (Coartem®) in 300 children aged six to 59 months with uncomplicated falciparum malaria. Inclusion was between December 2008 and May 2009. Randomization (1:1) was to a three-day observed oral regimen (ASAQ: once a day; AL: twice a day, given with fatty food). Day 7 desethylamodiaquine and lumefantrine blood-concentrations were also measured.
RESULTS
The day 42 genotyping-adjusted cure rate estimates were 97.3% [95% CI: 91.6-99.1] for ASAQ and 94.2% [88.1-97.2] for AL (Kaplan-Meier survival estimates). The difference in day 42 cure rates was -3.1% [upper limit 95% CI: 1.2%]. These results were confirmed by observed proportion of patients cured at day 42 on the per-protocol population. Parasite clearance was 100% (ASAQ) and 99.3% (AL) on day 3. The probability to remain free of re-infection was 0.55 [95% CI: 0.46-0.63] (ASAQ) and 0.66 [0.57-0.73] (AL) (p = 0.017).
CONCLUSIONS
Both ASAQ and AL were highly efficacious and ASAQ was non-inferior to AL. The proportion of patients with re-infection was high in both arms in this highly endemic setting. In 2010, ASAQ FDC was adopted as the first-line national treatment in Liberia. Continuous efficacy monitoring is recommended.
TRIAL REGISTRATION
The protocols were registered with Current Controlled Trials, under the identifier numbers ISRCTN51688713, ISRCTN40020296.
Prospective efficacy monitoring of anti-malarial treatments is imperative for timely detection of resistance development. The in vivo efficacy of artesunate-amodiaquine (ASAQ) fixed-dose combination (FDC) was compared to that of artemether-lumefantrine (AL) among children aged six to 59 months in Nimba County, Liberia, where Plasmodium falciparum malaria is endemic and efficacy data are scarce.
METHODS
An open-label, randomized controlled non-inferiority trial compared the genotyping adjusted day 42 cure rates of ASAQ FDC (ASAQ Winthrop®) to AL (Coartem®) in 300 children aged six to 59 months with uncomplicated falciparum malaria. Inclusion was between December 2008 and May 2009. Randomization (1:1) was to a three-day observed oral regimen (ASAQ: once a day; AL: twice a day, given with fatty food). Day 7 desethylamodiaquine and lumefantrine blood-concentrations were also measured.
RESULTS
The day 42 genotyping-adjusted cure rate estimates were 97.3% [95% CI: 91.6-99.1] for ASAQ and 94.2% [88.1-97.2] for AL (Kaplan-Meier survival estimates). The difference in day 42 cure rates was -3.1% [upper limit 95% CI: 1.2%]. These results were confirmed by observed proportion of patients cured at day 42 on the per-protocol population. Parasite clearance was 100% (ASAQ) and 99.3% (AL) on day 3. The probability to remain free of re-infection was 0.55 [95% CI: 0.46-0.63] (ASAQ) and 0.66 [0.57-0.73] (AL) (p = 0.017).
CONCLUSIONS
Both ASAQ and AL were highly efficacious and ASAQ was non-inferior to AL. The proportion of patients with re-infection was high in both arms in this highly endemic setting. In 2010, ASAQ FDC was adopted as the first-line national treatment in Liberia. Continuous efficacy monitoring is recommended.
TRIAL REGISTRATION
The protocols were registered with Current Controlled Trials, under the identifier numbers ISRCTN51688713, ISRCTN40020296.
Journal Article > ResearchFull Text
J Water Health. 2013 December 1; Volume 11 (Issue 4); 623-628.; DOI:10.2166/wh.2013.050
Gartley M, Valeh P, de Lange RFJ, Viscusi A, Lenglet AD, et al.
J Water Health. 2013 December 1; Volume 11 (Issue 4); 623-628.; DOI:10.2166/wh.2013.050
Médecins Sans Frontières-Operational Centre Amsterdam piloted the distribution of household disinfection kits (HDKs) and health promotion sessions for cholera prevention in households of patients admitted to their cholera treatment centres in Carrefour, Port au Prince, Haiti, between December 2010 and February 2011. We conducted a follow-up survey with 208 recipient households to determine the uptake and use of the kits and understanding of the health promotion messages. In 61% of surveyed households, a caregiver had been the recipient of the HDK and 57.7% of households had received the HDKs after the discharge of the patient. Among surveyed households, 97.6% stated they had used the contents of the HDK after receiving it, with 75% of these reporting using five or more items, with the two most popular items being chlorine and soap. A significant (p < 0.05) increase in self-reported use items in the HDK was observed in households that received kits after 24 January 2011 when the education messages were strengthened. To our knowledge, this is the first time it has been demonstrated that during a large-scale cholera outbreak, the distribution of simple kits, with readily available cleaning products and materials, combined with health promotion is easy, feasible, and valued by the target population.