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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 May 11, 2018

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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.
Show details

- 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.
Show details

- 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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Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia
A Phase 2/3, Randomized, Comparative, Double Blind Trial Of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia
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.
The trial was terminated prematurely 2 June 2005 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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Azithromycin/Chloroquine
  • Drug: Sulfadoxine-Pyrimethamine/Chloroquine
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
April 2005
Not Provided

Inclusion Criteria:

  • 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:

  • 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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Indonesia
 
NCT00084240
A0661123
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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