Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
NCT01103063
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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Publications * |
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* 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 | 2891 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |