Status:
COMPLETED
Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Ministry of Health and Population, Malawi
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is muc...
Eligibility Criteria
Inclusion
- Children age 6 - 59 months
- Axillary temperature ≥ 37.5 °C
- Monoinfection with P. falciparum
- Parasitaemia between 2000 - 200000 parasites/µl
- Haemoglobin concentration (finger-prick blood sample by HemoCue) \> 7g/dl
- Consent by the patient's adult guardian
- Residence in the locality and willingness to attend for scheduled visits
Exclusion
- altered consciousness
- convulsions
- prostration (inability to sit/stand/suck/drink)
- respiratory distress or breathlessness
- jaundice
- abnormal breathing
- haemoglobinuria
- circulatory collapse
- persistent vomiting (cannot keep down liquids)
- evidence of a diagnosis other than malaria on physical examination
- presence of mixed infection
- presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia)
- contraindications to the antimalarial drugs used, especially history of allergy
- history of receiving a drug with antimalarial activity in the week prior to enrollment
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00164710
Start Date
April 1 2005
End Date
September 1 2005
Last Update
September 27 2012
Active Locations (3)
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1
Kawale Health Center
Lilongwe, Lilongwe District, Malawi
2
Machinga District Hospital
Liwonde, Machinga District, Malawi
3
Matiki Health Center
Dwangwa, Nkhotakota District, Malawi