An RCT to measure the impact of retreatment with artemisinin-based combination on malaria incidence and resistant strains selection

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201203000351114
• Date of registration: 30/01/2012
• Primary sponsor: Jean-Pierre Van geertruyden
• Public title: An RCT to measure the impact of retreatment with artemisinin-based combination on malaria incidence and resistant strains selection
• Scientific title: A Randomized Clinical Trial to measure the impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains
• Date of first enrolment: 2012-05-16
• Target sample size: 310
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201203000351114
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; A randomisation list of blocks of varying size and stratified according to the number of recruitment points in each site will be used. ,; Sealed envelopes labelled with the patients unique code and containing the treatment allocated to the patient will be used. The envelopes will be opened only after recruitment. ,

Countries of recruitment

South Africa

Contacts

• Name: Joachim Y Doua
• Affiliation: Research assistant

• Name: Jean-Pierre Van geertruyden
• Affiliation: Study coordinator

Key inclusion & exclusion criteria

Inclusion criteria: In order to be eligible, patients should satisfy the following inclusion criteria:
1. Males and Females aged between 12 months and 59 months inclusive.
2. Body weight of 9 Kg and above.
3. Microscopically confirmed, mono-infection of Plasmodium falciparum (parasitaemia 2,000/microliter to 200,000/microliter).
4. Fever (tympanic temperature at ? 38.0?C) or history of fever in the previous 24 hours.
5. Haemoglobin value ? 6.0 g/dl;
6. Signed informed consents by the parents or guardians.
7. Parents? or guardians? willingness and ability to comply with the study protocol for the duration of the study.
Exclusion criteria: Patients with at least one of the following criteria will be excluded:
1. Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
2. Known hypersensitivity and previous Serious Adverse Events related to the study drugs.
3. Severe malaria( WHO 2000) or danger signs: not able to drink or breast-feed, vomiting (b twice in 24hours), recent history of convulsions (b1 in 24h), unconscious state, unable to sit or stand.
4. Presence of intercurrent illness or any condition (cardiac, renal, hematologic, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency.
5. Patients who are taking drug which may prolong the QT (imidazole and triazole, antifungal agent).
6. Severe malnutrition (defined as weight for height `70% of the median NCHS/WHO reference).
7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women

Age minimum: 12 Month
Age maximum: 59 Month
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
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Primary Outcome(s)

PCR adjusted efficacy: the proportion of children with PCR adequate clinical and parasitological response at day 28 (ACPR28A): all early failures before day 7 plus the recurrent parasitaemias detected later and classified by genotyping as recrudescence.

Secondary Outcome(s)

Asexual parasite clearance time (PCT): Asexual parasite clearance time is defined as the time (in days) from time of randomization to 2 consecutive negative blood slides (collected at different days). The time to the event will be taken as the time to the first negative slide.

Clinical efficacy: all clinical treatment failures detected during the 42 days follow up for the first line treatment, with and without PCR adjustment. As no active monitoring of parasitaemia after day 3 is planned this includes Early Treatment Failure and Late Clinical Failure following WHO criteria

Fever clearance time (FCT): Fever clearance time is defined as the time (in days) from the time of randomization to the first two consecutive measurements on 2 different days of tympanic temperature below 38.0?C.

Gametocytaemia (prevalence and density)

Hb changes

PCR unadjusted efficacy: the proportion of children without (PCR not adjusted) treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping

Source(s) of Monetary Support

Belgium Development Agency

EDCTP

Research Foundation Flanders / Fond voor Wetenschappelijk Onderzoek (FWO)