DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.


Intervention: Azithromycin/Chloroquine (Drug); Sulfadoxine-Pyrimethamine/Chloroquine (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Pfizer


This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.

Clinical Details

Official title: A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in India

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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 - 100,000 parasites/uL; b.)

Fever or history of fever ( >=38. 5C/101. 2F rectal or tympanic; >=37. 5C/99. 5F axillary or >=38C/100. 4F 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

- Women of childbearing potential must have a negative urine gonadotropin prior to

entry into the study and must agree to use adequate contraception during the entire study EXCLUSION CRITERIA:

- Severe or complicated malaria including subjects with any of the following: a.)

Impaired consciousness (e. g. obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria; b.) Hemoglobinuria; c.) Jaundice; d.) Respiratory distress (respiratory rate >=30/min); 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,

sulfonamides, pyrimethamine, or chloroquine

- Known or suspected folate deficiency

- Known history of blood dyscrasias (e. g., megaloblastic anemia, agranulocytosis,

aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)

- Known G-6PD deficiency

- History of epilepsy or psoriasis

- History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine,

Malarone, SP, 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.) Serum creatinine >2. 0 x ULN; b.) ALT and/or AST >3 x ULN

- Inability to swallow oral medication in tablet 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 to follow the study protocol

- Prior participation in this study

Locations and Contacts

Pfizer Investigational Site, Indore 452001, India

Pfizer Investigational Site, Dispur Guwahati, Assam 781006, India

Pfizer Investigational Site, Bambolim, Gao 403002, India

Pfizer Investigational Site, Nagpur, Maharashtra 440 018, India

Pfizer Investigational Site, Parel Mumbai, Maharashtra 400012, India

Pfizer Investigational Site, Rourkela, Orissa 769005, India

Pfizer Investigational Site, Vellore, Tamil Nadu 632 004, India

Additional Information

Starting date: September 2003
Last updated: May 9, 2011

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017