N/A
N=79
Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT02600767 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Absence of Malaria Parasites in Blood. — 73 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Artemether-lumefantrine combination (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Malaria Parasites in Blood. |
73 | — |
Summary
This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions. The results of this efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to evaluate the national policy for treatment of malaria caused by P. falciparum.
Eligibility Criteria
Inclusion Criteria
- >= 5 years
- body weight 3 mg/dl or clinical signs), pulmonary edema, hypoglycemia (blood glucose < 40 mg/dl or clinical signs), shock (systolic blood pressure < 70 mmHg for adults; < 50 mmHg for children), spontaneous hemorrhage/disseminated intravascular coagulation, repeated generalized seizures, acidemia/acidosis (clinical signs), macroscopic hemoglobinuria, and jaundice.
- history of chronic or severe underlying diseases (e.g. heart, renal or liver diseases, HIV/AIDS, tuberculosis, malnourishment)
- history of hypersensitivity to AL
- current pregnancy (history of current pregnancy or positive pregnancy test)
- use of any antimalarial drug in the previous 30 days.
Data sourced from ClinicalTrials.gov (NCT02600767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.