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Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Medicines for Malaria Venture
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01103063
First received: April 7, 2010
Last updated: May 14, 2015
Last verified: May 2015
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Intermittent Preventive Treatment In Pregnancy (IPTp)
Interventions: Drug: Azithromycin plus chloroquine
Drug: sulfadoxine-pyrimethamine

  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
This Phase 3, open label, randomized, parallel group study screened a total of 3259 participants in 6 sites. A total of 2891 were treated either with azithromycin+chloroquine or sulfadoxine+pyrimethamine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age were to be enrolled in this study. Approximately half of the participants were to be primigravidae and secundigravidae pregnant women since they had a higher risk for suboptimal pregnancy outcomes due to malaria.

Reporting Groups
  Description
Azithromycin + Chloroquine The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
Sulfadoxine + Pyrimethamine The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.

Participant Flow:   Overall Study
    Azithromycin + Chloroquine   Sulfadoxine + Pyrimethamine
STARTED   1446   1445 
COMPLETED   969   1024 
NOT COMPLETED   477   421 
Adverse Event                3                1 
Lost to Follow-up                68                51 
Withdrawal by Subject                60                15 
Not specified                16                11 
Protocol Violation                1                0 
Study terminated by Sponsor                326                342 
Death                3                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.
No text entered.

Reporting Groups
  Description
Azithromycin + Chloroquine The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
Sulfadoxine + Pyrimethamine The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
Total Total of all reporting groups

Baseline Measures
   Azithromycin + Chloroquine   Sulfadoxine + Pyrimethamine   Total 
Overall Participants Analyzed 
[Units: Participants]
 1446   1445   2891 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.3  (4.5)   23.3  (4.6)   23.3  (4.6) 
Gender 
[Units: Participants]
     
Female   1446   1445   2891 
Male   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population   [ Time Frame: Approximately 40 weeks of gestational age ]

2.  Secondary:   Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population   [ Time Frame: Approximately 40 weeks of gestational age ]

3.  Secondary:   Percentage of Neonates With LBW (<2500 g) in ITT Population   [ Time Frame: Approximately 40 weeks of gestational age ]

4.  Secondary:   Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population   [ Time Frame: Approximately 40 weeks of gestational age ]

5.  Secondary:   Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation. ]

6.  Secondary:   Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation. ]

7.  Secondary:   Percentage of Participants With Placental Parasitemia at Delivery   [ Time Frame: Approximately 40 weeks of gestational age ]

8.  Secondary:   Percentage of Participants With Placental Malaria at Delivery Based on Histology   [ Time Frame: Approximately 40 weeks of gestational age ]

9.  Secondary:   Sexually Transmitted Infection (STI) Episodes Per Participant   [ Time Frame: Approximately 40 weeks of gestational age . ]

10.  Secondary:   Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation   [ Time Frame: Approximately 40 weeks of gestational age. ]

11.  Secondary:   Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.   [ Time Frame: Baseline, at 36-38 weeks of gestation. ]

12.  Secondary:   Percentage of Neonates With Congenital Abnormalities at Birth   [ Time Frame: Approximately 40 weeks of gestational age. ]

13.  Secondary:   Percentage of Perinatal or Neonatal Deaths   [ Time Frame: Day 28 after delivery. ]

14.  Secondary:   Birth Weight of Live Borne Neonate   [ Time Frame: Approximately 40 weeks of gestational age. ]

15.  Secondary:   Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery   [ Time Frame: Approximately 40 weeks of gestational age ]

16.  Secondary:   Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery   [ Time Frame: Approximately 40 weeks of gestational age ]

17.  Secondary:   Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation ]

18.  Secondary:   Percentage of Participants With Peripheral Parasitemia at Delivery   [ Time Frame: Approximately 40 weeks of gestational age ]

19.  Secondary:   Percentage of Participants With Cord Blood Parasitemia at Delivery   [ Time Frame: Approximately 40 weeks of gestational age ]

20.  Secondary:   Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation   [ Time Frame: Upto 36-38 weeks of gestation ]

21.  Secondary:   Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation ]

22.  Secondary:   Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation ]

23.  Secondary:   Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation ]

24.  Secondary:   Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation   [ Time Frame: At 36-38 weeks of gestation ]

25.  Secondary:   Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.   [ Time Frame: At 36-38 weeks of gestation ]

26.  Secondary:   Percentage of Neonates With Ophthalmia Neonatorum at Birth Period   [ Time Frame: Approximately 40 weeks of gestational age ]

27.  Secondary:   Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery   [ Time Frame: Up to approximately 40 weeks of gestational age ]

28.  Secondary:   Percentage of Participants With Pre-eclampsia From Week 20 to Delivery   [ Time Frame: From Week 20 to approximately 40 weeks of gestational age ]

29.  Secondary:   Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae   [ Time Frame: Visits 6 and 7 ]

30.  Secondary:   Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae   [ Time Frame: Visits 6 and 7 ]


  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
This program was terminated by Pfizer based on the results of the pre-planned interim analysis for this pivotal study. The interim analysis showed no benefit of the study drug (AZCQ) compared to standard of care (SP).


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01103063     History of Changes
Other Study ID Numbers: A0661158
Study First Received: April 7, 2010
Results First Received: August 25, 2014
Last Updated: May 14, 2015