None listed
Conditions
Interventions
Azithromycin 1000 mg + chloroquine 600 mg Type of group
Azithromycin 1000 mg PO (two 500 mg tablets) once a day for three days (Days 0,1,2) + cbloroquine 600 mg base PO once a day for three days (Days 0,1,2) and corresponding placebo for atovaquone-proguanil (four tabs placebo PO once a day for three days (days 0,1,2).
Group name:Atovaquone 250 mg-proguanil 100 mg Type of group
Atovaquone 250 mg-proguanil 100 mg, four tabs PO once daily for three days (Days 0,1,2) and matching placebo for azithromycin and chloroquine: azithromycin two placebo tablets once daily for three days (Days 0,1,2) + chloroquine placebo matching 600 mg base PO once daily for three days (Days 0,1,2)
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Written informed consent of the subject or a legally authorized representative Females and males >= 18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 - 40,000 parasites/mL; b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection) Positive rapid diagnostic test (Binax NOW ICT) positive for P. falciparum Subjects must be willing to be treated in the inpatient setting for a minimum of three days or more until parasitemia has cleared and the Investigator deems the subject fit for discharge Women of childbearing potential (that is, women who have not been surgically sterilized or are not clearly post-menopausal), must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study and for one month after the last study visit
Exclusion criteria
Exclusion criteria: Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness (e.g. obtundation, unarousable coma, delirium, stupor), seizures (any seizure within a 24 hour prior to enrollment) or abnormal neurologic exam suggestive of severe or complicated malaria b.) Hemoglobinuria c.) Jaundice d.) Respiratory distress (respiratory rate ≥ 30 breaths/minute) e.) Persistent vomiting f.) Hematuria, as reported by the patient Pregnant or breast-feeding women History of allergy to or hypersensitivity to azithromycin or any macrolide, atovaquone, proguanil or chloroquine Concomitant administration of rifampin or rifabutin and metoclopramide History of epilepsy or psoriasis History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, atovaquone/proguanil, sulfadoxine/pyrimethamine, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) Known or suspected creatinine clearance 3 x upper limit of normal Inability to swallow oral medication in tablet or capsule form Treatment with other investigational drugs within 30 days prior to enrollment into the study Alcohol and/or any other drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs and symptoms of malaria Sample of whole blood (7 mL) and dried blood blot (100 pL x2) to obtain isolate of parasite, if smear positive. Measure:parasite removal Timepoints:days 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:serious adverse event is any adverse drug experience occurring at any dose that: 1. Results in death; 2. Is life-threatening; 3. Results in inpatient hospitalization or prolongation of existing hospitalization; 4. Results in a persistent or significant disability/incapacity; or 5. Results in congenital anomaly/birth defect. Measure:Tolerability and safety Timepoints:day 28 | — |
Countries
Peru
Outcome results
None listed