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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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Centre de Santé d'AHOUANSORI-AGUE
Cotonou, , Benin
Contact
1-800-718-1021
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

- 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 35 years old.

- Multiple gestations as per the ultrasound at screening.

- Clinical symptoms of malaria.

- Hemoglobin

- 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.

NCT01103063
Pfizer
Terminated
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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Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Intermittent Preventive Treatment In Pregnancy (IPTp)
  • 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
  • Experimental: AZCQ
    Azithromycin/chloroquine
    Intervention: Drug: Azithromycin plus chloroquine
  • Active Comparator: SP
    sulfadoxine-pyrimethamine (Fansidar)
    Intervention: Drug: sulfadoxine-pyrimethamine
Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2891
November 2013
October 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
16 Years to 35 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Benin,   Kenya,   Malawi,   Tanzania,   Uganda
 
 
NCT01103063
A0661158
Yes
Not Provided
Not Provided
Pfizer
Pfizer
  • London School of Hygiene and Tropical Medicine
  • Medicines for Malaria Venture
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2015

ICMJE     Data element required by the

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

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