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Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

Last updated on December 16, 2017

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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
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT00082563
Pfizer
Terminated
Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

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Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum
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
The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Azithromycin/Chloroquine
  • Drug: 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
14
November 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00082563
A0661121
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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