Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar (AcoI)
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|ClinicalTrials.gov Identifier: NCT03764527|
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : December 6, 2018
The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®.
Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum Malaria||Drug: Artemether-lumefantrine Drug: Coadministered Artesunate plus Amodiaquine||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A comparative randomised study comparing oral treatment with AQ + AS and CO of uncomplicated falciparum malaria in children.|
|Masking:||None (Open Label)|
|Masking Description:||The AQ+AS (AA) group received their drugs under direct observation once daily for 3 days. The Coartem (CO) group received their drugs twice daily, the second (evening) dose also under supervision. Drug treatment was thus not be blinded.|
|Official Title:||Randomized Study of the Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate Plus Amodiaquine Coadministered for the Treatment of Uncomplicated Falciparum Malaria in Zanzibar|
|Actual Study Start Date :||November 1, 2002|
|Actual Primary Completion Date :||February 17, 2003|
|Actual Study Completion Date :||February 17, 2003|
Active Comparator: Artemether-lumefantrine (AL)
One tablet of artemether-lumefantrine (Coartem®) was administered twice daily for 3 days to children with a body weight of 9 to <15 kg, and 2 tablets were administered twice daily for 3 days to children with a body weight of >15 to 25 kg. All doses were taken under direct observation.
Two doses a day for 3 days, under supervision
Other Name: Coartem®
Active Comparator: Artesunate + Amodiaquine (AA)
Artesunate + amodiaquine (ASAQ) was administered as follows: 4 mg/kg body weight of artesunate plus 10 mg/kg body weight of amodiaquine once daily for 3 days under direct observation.
Drug: Coadministered Artesunate plus Amodiaquine
One dose a day for 3 days, under supervision
- PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine (AA) or Coartem® (CO) [ Time Frame: 42 days ]Comparing PCR adjusted parasitological cure rate (PCR-APCR) between the two treatment options up to day 42. Parasitological cure will be adjusted using PCR genotyping of msp2 marker. Recrudescence is defined as the presence of at least one matching allelic band, and reinfection as the absence of any matching allelic band on day 0 and day of recurring parasitaemia. Patients with recurrent parasitaemia having missing filter paper sample or negative PCR results will be considered uncertain with regards to PCR adjusted outcome.
- Safety of treatment with Artesunate + Amodiaquine (AA) or Coartem® (CO): Proportion of subjects with adverse events [ Time Frame: 42 days ]Proportion of subjects with adverse events, including early vomiting and mean values of white blood cells (WBC) and neutrophils
- Parasite clearance [ Time Frame: 42 days ]Proportion of patients with microscopy detectable parasitaemia at each time point
- Gametocyte carriage [ Time Frame: 42 days ]Proportion of patients with microscopy detectable gametocytes at each time point
- Fever clearance [ Time Frame: 42 days ]Proportion of patients with fever at each time point
- Hemoglobin [ Time Frame: 42 days ]Mean and individual hemoglobin values at different time points during follow up
- Selection of mutations in P. falciparum related to the resistance of the study drugs [ Time Frame: 42 days ]Change in possible selections of mutations related to quinoline resistance. Percentage of pfcrt and pfmdr1 mutations on day 0 and day of recurrent infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764527
|Principal Investigator:||Abdullah Ali||Zanzibar Malaria Control Programme|