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

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NCT01103063

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Study Location
Centre de Santé d'AHOUANSORI-AGUE
Cotonou, , , Benin
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intermittent Preventive Treatment In Pregnancy (IPTp)
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-35 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).

- Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.

- Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

- Subjects who are available for follow up at delivery and on 28 days post delivery.

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


- Age <16 years old or >35 years old.


- Multiple gestations as per the ultrasound at screening.


- Clinical symptoms of malaria.


- Hemoglobin < 8 g/dL (at enrollment).


- Any condition requiring hospitalization at enrollment.


- History of convulsions, hypertension, diabetes or any other chronic illness that may
adversely affect fetal growth and viability.


- Inability to tolerate oral treatment in tablet form.


- Known allergy to the study drugs (azithromycin, chloroquine, and
sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.


- Requirement to use medication during the study that might interfere with the
evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects
positive for HIV infection.


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation.


- Evidence of current obstetric complications that may adversely impact the pregnancy
and/or fetal outcomes, including presence of congenital anomalies, placenta previa or
abruption.


- Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.


- Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or
sudden cardiac death.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Intermittent Preventive Treatment In Pregnancy (IPTp)Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa NCT01103063
  1. Cotonou,
  2. Cotonou,
  3. Siaya,
  4. Zomba,
  5. Muheza, Tanga
  6. Mwanza,
  7. Mwanza,
  8. Mwanza,
  9. Kampala,
Female
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Official Title  ICMJE A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Brief Summary The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
Detailed Description After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Intermittent Preventive Treatment In Pregnancy (IPTp)
Intervention  ICMJE
  • Drug: Azithromycin plus chloroquine
    combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
  • Drug: sulfadoxine-pyrimethamine
    Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
    Other Name: Fansidar
Study Arms  ICMJE
  • Experimental: AZCQ
    Azithromycin/chloroquine
    Intervention: Drug: Azithromycin plus chloroquine
  • Active Comparator: SP
    sulfadoxine-pyrimethamine (Fansidar)
    Intervention: Drug: sulfadoxine-pyrimethamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)		2891
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)		4206
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women (all gravidae) with ?14 and ?26 weeks of gestational age (by ultrasound).
  • Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
  • Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Subjects who are available for follow up at delivery and on 28 days post delivery.

Exclusion Criteria:

  • Age <16 years old or >35 years old.
  • Multiple gestations as per the ultrasound at screening.
  • Clinical symptoms of malaria.
  • Hemoglobin < 8 g/dL (at enrollment).
  • Any condition requiring hospitalization at enrollment.
  • History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
  • Inability to tolerate oral treatment in tablet form.
  • Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
  • Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
  • Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
  • Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
  • Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Benin,   Kenya,   Malawi,   Tanzania,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103063
Other Study ID Numbers  ICMJE A0661158
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • London School of Hygiene and Tropical Medicine
  • Medicines for Malaria Venture
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP