Comparative Efficacy, Safety And Tolerability Of Three Treatment Regiments For Uncomplicated Falciparum Malaria
- Conditions
- Malaria
- Registration Number
- PACTR201802003020160
- Lead Sponsor
- SANOFI-SYNTHELABO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 750
The following criteria needed to be met for intry into the study:
- Adults or children aged 6 months or older and weighing more than 5Kg
- Residents of Bougoula-Hameau during the entire follow up period
- Oral treatment possible
- Axiliary temperature >= 37.5oC .
- Infection with Plasmodium specie with parasite density between 2000 and 200000
trophozoites/mm3.
- Informed consent or informed assent obtained from the patient or parent/guardian
EXCLUSION CRITERIA
- Presence of symptoms of severe or cerebral malaria: coma, unconsciousness, recent or
repeated seizures, acute pulmonary edema, unable to drink, repeated vomiting,
macroscopic hemoglobinueria, jaundice, hemorrhagic shock (systolic blood pressure <
70 mm Hg in adults, <50 in children), spontaneous bleeding, hypoglycemia (<40mg/dl),
renal failure (creatinine > 3mg/dL).
- Concomitant severe illness,
- Severe anemia: hemoglobine <= 5g/dL
- Allergy to one of the study drugs
- Pregnancy (disclosed or clinically patent pregnancy).
- Documented consumption of one of the study drugs during the preceding 7 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Treatment Efficacy;Tolerance and safety:
- Secondary Outcome Measures
Name Time Method Efficacy, tolerance and safety