First line therapy for uncomplicated falciparum malaria with Coartem® and Coarsucam® in Burkina Faso

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN71912942
• Lead Sponsor: Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

1. Not previously enrolled in this study
2. Both males and females, aged greater than 6 months
3. Weight greater than 5 kg
4. Fever (greater than 37.5ºC axillary) or history of fever in the previous 24 hours
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. Provision of informed consent and ability to participate in 28-day follow-up (patient has easy access to health unit)
8. No danger signs or evidence of severe malaria defined as:
8.1. Unarousable coma (if after convulsion, greater than 30 minutes)
8.2. Repeated convulsions (greater than two within 24 hours)
8.3. Recent convulsions (one to two within 24 hours)
8.4. Altered consciousness (confusion, delirium, psychosis, coma)
8.5. Lethargy
8.6. Unable to drink or breast feed
8.7. Vomiting everything
8.8. Unable to stand/sit due to weakness
8.9. Severe anaemia (Hb less than 5.0 g/dL)
8.10. Respiratory distress (laboured breathing at rest)
8.11. Jaundice
9. Plasmodium falciparum mono-infection
10. Parasite density greater than 2,000/ul and less than 200,000/ul

Exclusion Criteria

1. Severe malaria
2. Unable to comply with planned follow up
3. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified