Completed
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
What is being tested
Data Collection
Who is being recruted
Vector Borne Diseases+4
+ Mosquito-Borne Diseases
+ Infections
Over 18 Years
+20 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2 & 3
Interventional
Study Start: September 2003
Summary
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.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.
Official TitleA 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
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
230 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Vector Borne DiseasesMosquito-Borne DiseasesInfectionsMalariaParasitic DiseasesProtozoan InfectionsMalaria, Falciparum
Criteria
4 inclusion criteria required to participate
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
16 exclusion criteria prevent from participating
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
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Suspended
Suspended
Pfizer Investigational Site
Bambolim, IndiaSuspended
Pfizer Investigational Site
Nagpur, IndiaSuspended
Pfizer Investigational Site
Parel Mumbai, IndiaCompleted7 Study Centers