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A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00282919
First received: January 26, 2006
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Falciparum Malaria
Intervention: Drug: Azithromycin plus chloroquine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Azithromycin and Chloroquine Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.

Participant Flow:   Overall Study
    Azithromycin and Chloroquine  
STARTED     110  
COMPLETED     103  
NOT COMPLETED     7  
Lack of Efficacy                 4  
Withdrawal by Subject                 1  
Asymptomatic Parasitemia                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated population included participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Azithromycin and Chloroquine Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.

Baseline Measures
    Azithromycin and Chloroquine  
Number of Participants  
[units: participants]
  110  
Age  
[units: years]
Mean ± Standard Deviation
  30.8  ± 13.0  
Gender  
[units: participants]
 
Female     25  
Male     85  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Parasite Clearance at Day 28   [ Time Frame: Day 28 ]

2.  Secondary:   Percentage of Participants With Early Treatment Failures (ETF)   [ Time Frame: Baseline up to Day 28 ]

3.  Secondary:   Percentage of Participants With Late Treatment Failures (LTF)   [ Time Frame: Baseline up to Day 28 ]

4.  Secondary:   Percentage of Participants With Resistance to Treatment   [ Time Frame: Days 7, 14, 21, 28, 35, 42 ]

5.  Secondary:   Percentage of Participants With Clinical Cure   [ Time Frame: Day 3, 7, 28, and 42 ]

6.  Secondary:   Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42   [ Time Frame: Day 7, 14, 21, 35, 42 ]

7.  Secondary:   Percentage of Participants With Gametocyte Clearance   [ Time Frame: Day 7, 14, 21, 28, 35, 42 ]

8.  Secondary:   Fever Clearance Time   [ Time Frame: Baseline up to Day 42 ]

9.  Secondary:   Parasite Clearance Time   [ Time Frame: Baseline up to Day 42 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00282919     History of Changes
Other Study ID Numbers: A0661154
Study First Received: January 26, 2006
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration