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

Last updated on February 17, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Falciparum Malaria
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

- 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 (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

NCT00084240
Pfizer
Terminated
Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

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