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Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01103713
First received: April 7, 2010
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: July 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asymptomatic Parasitemia In Pregnancy
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
Participants were enrolled at 5 active sites in 5 countries: Benin (site 1012), Kenya (site 1004), Malawi (site 1015), Tanzania (site 1008), and Uganda (site 1013). The enrollment of the first participant took place on 07 March 2011 and the last participant last visit was on 25 October 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 404 participants were screened and 168 participants were assigned to study drug, enrolled and treated. Of the 168 participants, two participants were excluded from the pharmacokinetic (PK) analysis, modified intent-to-treat (MITT), intent-to-treat (ITT) and per protocol (PP) populations due to informed consent protocol deviations.

Reporting Groups
  Description
Azithromycin (AZ)/Chloroquine (CQ) Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).

Participant Flow:   Overall Study
    Azithromycin (AZ)/Chloroquine (CQ)
STARTED   168 
COMPLETED   155 
NOT COMPLETED   13 
Lost to Follow-up                2 
Withdrawal by Subject                8 
Study terminated by sponsor                2 
Not specified                1 



  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.
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Reporting Groups
  Description
Azithromycin (AZ)/Chloroquine (CQ) Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).

Baseline Measures
   Azithromycin (AZ)/Chloroquine (CQ) 
Overall Participants Analyzed 
[Units: Participants]
 168 
Age, Customized 
[Units: Participants]
 
<16 years   0 
16-17 years   41 
18-25 years   125 
26-30 years   1 
31-35 years   1 
>35 years   0 
Gender 
[Units: Participants]
 
Female   168 
Male   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication   [ Time Frame: Day 28 ]

2.  Primary:   Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication   [ Time Frame: Day 28 ]

3.  Secondary:   Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 35, and 42 ]

4.  Secondary:   Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 35, and 42 ]

5.  Secondary:   Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

6.  Secondary:   Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

7.  Secondary:   Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

8.  Secondary:   Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

9.  Secondary:   Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

10.  Secondary:   Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

11.  Secondary:   Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication   [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]

12.  Other Pre-specified:   Summary of Pregnancy Outcome: Location of Delivery   [ Time Frame: Following delivery or pregnancy termination ]

13.  Other Pre-specified:   Summary of Pregnancy Outcome: Mode of Delivery   [ Time Frame: Following delivery or pregnancy termination ]

14.  Other Pre-specified:   Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?   [ Time Frame: Following delivery or pregnancy termination ]

15.  Other Pre-specified:   Summary of Pregnancy Outcome: Labor Induced?   [ Time Frame: Following delivery or pregnancy termination ]

16.  Other Pre-specified:   Summary of Pregnancy Outcome: Complications During Delivery?   [ Time Frame: Following delivery or pregnancy termination ]

17.  Other Pre-specified:   Summary of Pregnancy Outcome: Outcome of Birth   [ Time Frame: Following delivery or pregnancy termination ]

18.  Other Pre-specified:   Incidence of Fever Based on Oral Temperature   [ Time Frame: Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42 ]

19.  Other Pre-specified:   Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level   [ Time Frame: Day 42 ]

20.  Other Pre-specified:   Summary of Serum Azithromycin Concentration Versus Time   [ Time Frame: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming "hour not specified" as 0 hours on Day 7 and Day 14 for planned time post first dose calculation. ]

21.  Other Pre-specified:   Summary of Plasma Chloroquine Concentration Versus Time   [ Time Frame: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation. ]

22.  Other Pre-specified:   Summary of Plasma Desethylchloroquine Concentration Versus Time   [ Time Frame: Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming "hour not specified" as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation. ]


  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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01103713     History of Changes
Other Study ID Numbers: A0661201
Study First Received: April 7, 2010
Results First Received: July 16, 2014
Last Updated: January 22, 2015