Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
- Conditions
- Intermittent Preventive Treatment In Pregnancy (IPTp)MedDRA version: 17.1Level: PTClassification code 10025487Term: MalariaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-004952-80-Outside-EU/EEA
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Female
- Target Recruitment
- 2891
1. Pregnant women (all gravidae) with greater than or equal to (>=) 14 and less than or equal to (<=) 26 weeks of gestational age (by ultrasound).
2. Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
3. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
4. Subjects agreeing to be supervised for treatment administration, and available for all follow up visits as per protocol, including follow ups at delivery and on 28 days post-delivery.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2891
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2709
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Age <16 years old or >35 years old.
2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.
3. Clinical symptoms of malaria.
4. Hemoglobin <8 g/dL (measured at baseline).
5. Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
6. Use of antimalarial drugs in previous 4 weeks.
7. History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
8. Inability to tolerate oral treatment in tablet form.
9. Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
10. Present history of smoking or alcohol or drug abuse since first becoming aware of current pregnancy.
11. Participation in other studies within 30 days before the current study begins and/or during study participation.
12. Inability to comprehend and/or unwillingness to follow the study protocol.
13. Concurrent participation in another investigational study.
14. 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 Human immunodeficiency virus [HIV] infection) or contra-indicated during pregnancy per package inserts.
15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
16. Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
17. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
18. Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or
sudden cardiac death.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method