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

Not Applicable

Recruiting

• Conditions: Malaria

• Registration Number: PACTR201203000351114
• Lead Sponsor: Jean-Pierre Van geertruyden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 310

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 (> twice in 24hours), recent history of convulsions (>1 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified