A Phase II, Randomized, Comparative Trial Of Azithromycin In Combination With Chloroquine Versus Chloroquine In The Eradication Of Asymptomatic Plasmodium Falciparum Infection In Semi-Immune Adults
Data Collection
Vector Borne Diseases+4
+ Mosquito-Borne Diseases
+ Infections
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.The trial was terminated prematurely 9 November 2004 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Healthy adult: male or female * Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/μL * Age 18 years to 60 years * Willingness to sign and ability to understand consent form * Willingness and ability to return for scheduled follow up visits Exclusion Criteria: * Mixed malaria infection by Giemsa smear * History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin) * Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study * Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting) * Inability to swallow oral medication * Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality * Any situation which could prevent the patient from returning to follow up visits * Pregnancy or breast feeding * Any other concurrent illness that may confound the result * Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives