Plasmodium Falciparum Malaria Clinical Trial
— AcoIOfficial 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
Verified date | December 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 408 |
Est. completion date | February 17, 2003 |
Est. primary completion date | February 17, 2003 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: - Children age 6-59 months and body weight =6 kg (AQ+AS); 9-59 months and body weight =9 kg (AL) - Fever or history of fever in the preceding 24 hours - Parasitemia =2000 =200.000 parasites per µl - Informed consent given by the child's parent or other adult guardian Exclusion Criteria: - Signs of severe malaria or other danger signs, such as: 1.Unconsciousness; 2. Not able to sit or stand; 3.Severe anaemia (Hb = 5 g/dl); 4.Convulsions; 5. Shock (systolic BP<50 mmHg); 6. Not able to drink or breastfeed; 7. Vomiting 3 times or more the past 24 hrs - Other diseases associated with fever - History of allergy to test drugs - History of intake of any drugs other than paracetamol and aspirin within 3 days |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Professor Anders Björkman | World Health Organization, Zanzibar Malaria Control Programme |
Holmgren G, Hamrin J, Svärd J, Mårtensson A, Gil JP, Björkman A. Selection of pfmdr1 mutations after amodiaquine monotherapy and amodiaquine plus artemisinin combination therapy in East Africa. Infect Genet Evol. 2007 Sep;7(5):562-9. Epub 2007 Mar 31. — View Citation
Mårtensson A, Strömberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Björkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum mala — View Citation
Sisowath C, Ferreira PE, Bustamante LY, Dahlström S, Mårtensson A, Björkman A, Krishna S, Gil JP. The role of pfmdr1 in Plasmodium falciparum tolerance to artemether-lumefantrine in Africa. Trop Med Int Health. 2007 Jun;12(6):736-42. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine (AA) or Coartem® (CO) | 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. | 42 days | |
Secondary | Safety of treatment with Artesunate + Amodiaquine (AA) or Coartem® (CO): Proportion of subjects with adverse events | Proportion of subjects with adverse events, including early vomiting and mean values of white blood cells (WBC) and neutrophils | 42 days | |
Secondary | Parasite clearance | Proportion of patients with microscopy detectable parasitaemia at each time point | 42 days | |
Secondary | Gametocyte carriage | Proportion of patients with microscopy detectable gametocytes at each time point | 42 days | |
Secondary | Fever clearance | Proportion of patients with fever at each time point | 42 days | |
Secondary | Hemoglobin | Mean and individual hemoglobin values at different time points during follow up | 42 days | |
Secondary | Selection of mutations in P. falciparum related to the resistance of the study drugs | Change in possible selections of mutations related to quinoline resistance. Percentage of pfcrt and pfmdr1 mutations on day 0 and day of recurrent infection. | 42 days |
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