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Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

Last updated on February 17, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Navrongo, , Ghana
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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Written informed consent of the subject or a legally authorized representative

- 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
monoinfection, with 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)

- Rapid diagnostic test (Binax NOW ICT) positive for P. falciparum

- Subjects must be willing to be treated in the inpatient setting for a minimum of three
days

- 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 (e.g. obtundation, unarousable coma), seizures (any seizure
within 24 hours prior to enrollment) 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

- Presence of non-falciparum species on microscopy

- Pregnant or breast-feeding women

- History of allergy to or hypersensitivity to azithromycin or any macrolide, mefloquine
or related compounds (e.g. quinine and quinidine), 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

- Active depression or a recent history of depression, generalized anxiety disorder,
psychosis, schizophrenia or other major psychiatric disorders

- 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

NCT00082576
Pfizer
Completed
Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

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[email protected]

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1-800-718-1021

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