Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00084227
• Date of registration: 09/06/2004
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America
• Scientific title: A Phase Ii/Iii, Randomized, Double Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America
• Date of first enrolment: July 2004
• Target sample size: 244
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00084227
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Colombia, Suriname

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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:

- 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 <30 mL/min b.) ALT and/or AST > 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

- Requirement to use medication during the study that might interfere with the
evaluation of the study drug

- Specific systemic diseases or other medical conditions that would interfere with the
evaluation of the therapeutic response or safety of the study drug

- Inability to comprehend and/or unwillingness follow to the study protocol

- Prior participation in this study



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria, Falciparum

Intervention(s)

Drug: Atovaquone/Proguanil

Drug: Azithromycin/Chloroquine

Primary Outcome(s)

parasite clearance

Secondary Outcome(s)

tolerability and safety

Secondary ID(s)

A0661126

Source(s) of Monetary Support

Please refer to primary and secondary sponsors