Status:
TERMINATED
Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children
Lead Sponsor:
Albert Schweitzer Hospital, Netherlands
Collaborating Sponsors:
Albert Schweitzer Hospital
Bill and Melinda Gates Foundation
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. Howe...
Detailed Description
Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment, if eligible according to the approved protocol. 139 subjec...
Eligibility Criteria
Inclusion
- Male and female outpatients
- Aged 6 to 59 months
- Body weight between 7.5 to 30 kg
- uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL
- Ability to tolerate oral therapy
- Informed consent, oral agreement of the child if appropriate
Exclusion
- Still in IPTi trial and/or still in any other intervention trial
- Known G6PD-deficiency
- Presence of severe malnutrition
- Inability to drink or breastfeed
- Recent history of convulsions, lethargy or unconsciousness;
- Signs of severe and complicated
- Mixed/mono infection that includes a non-P. falciparum species.
- Hb \< 7g/dl
- Inability to attend stipulated follow-up visits.
- History of hypersensitivity reactions to the drug being evaluated
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00453856
Start Date
March 1 2007
Last Update
August 10 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, Gabon, B.P. 118