Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

NCT00084240 | Terminated Phase 2

• 1 other identifier: A0661123
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.

Conditions

Malaria, Falciparum

Outcome Measures

Primary Outcomes (1)

• parasite clearance

Secondary Outcomes (1)

• tolerability and safety

Interventions

Azithromycin/Chloroquine DRUG

Sulfadoxine-Pyrimethamine/Chloroquine DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/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) 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

You may not qualify if:

• Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density \> 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy
• Pregnant or breast-feeding women
• History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine
• Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)
• 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
• 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 (nelfinavir, digoxin, ergot alkaloids, terfenadine, cyclosporine, hexobarbital and phenytoin)
• 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 the study protocol
• Intentions to leave the vicinity of the trial site in the next 42 days
• Prior participation in this study

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Azithromycin; Chloroquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Study Completion: April 1, 2005
• Last Updated: November 3, 2008

Record last verified: 2008-10