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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

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) Population

Percentage 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

Page last updated: August 23, 2015

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