Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intermittent Preventive Treatment In Pregnancy (IPTp)
Intervention: Azithromycin plus chloroquine (Drug); sulfadoxine-pyrimethamine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Secondary outcome: Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) PopulationPercentage of Neonates With LBW (<2500 g) in ITT Population Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation Percentage of Participants With Placental Parasitemia at Delivery Percentage of Participants With Placental Malaria at Delivery Based on Histology Sexually Transmitted Infection (STI) Episodes Per Participant Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration. Percentage of Neonates With Congenital Abnormalities at Birth Percentage of Perinatal or Neonatal Deaths Birth Weight of Live Borne Neonate Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation Percentage of Participants With Peripheral Parasitemia at Delivery Percentage of Participants With Cord Blood Parasitemia at Delivery Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation. Percentage of Neonates With Ophthalmia Neonatorum at Birth Period Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery Percentage of Participants With Pre-eclampsia From Week 20 to Delivery Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Centre de Santé d'AHOUANSORI-AGUE, Cotonou, Benin
Hôpital Bethesda, Cotonou, Benin
Siaya District Hospital, Siaya, Kenya
Zomba Central Hospital, Zomba, Malawi
Bugando Medical Centre, Mwanza 1903, Tanzania
Nyamagana District Hospital, Mwanza, Tanzania
Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre, Mwanza, Tanzania
Mulago Hospital Complex, Kampala, Uganda
Teule Hospital, Muheza, Tanga, Tanzania
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2010
Last updated: May 14, 2015
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