Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01103063
• Date of registration: 07/04/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
• Scientific 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
• Date of first enrolment: October 2010
• Target sample size: 2891
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01103063
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Benin, Kenya, Malawi, Tanzania, Uganda

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Intermittent Preventive Treatment In Pregnancy (IPTp)

Intervention(s)

Drug: Azithromycin plus chloroquine

Drug: sulfadoxine-pyrimethamine

Primary Outcome(s)

Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population [Time Frame: Approximately 40 weeks of gestational age]

Secondary Outcome(s)

Percentage of Neonates With Ophthalmia Neonatorum at Birth Period [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants With Placental Malaria at Delivery Based on Histology [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation [Time Frame: Upto 36-38 weeks of gestation]

Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration. [Time Frame: Baseline, at 36-38 weeks of gestation.]

Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae [Time Frame: Visits 6 and 7]

Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation]

Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation [Time Frame: Approximately 40 weeks of gestational age.]

Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation]

Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation.]

Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae [Time Frame: Visits 6 and 7]

Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery [Time Frame: Up to approximately 40 weeks of gestational age]

Birth Weight of Live Borne Neonate [Time Frame: Approximately 40 weeks of gestational age.]

Percentage of Neonates With Congenital Abnormalities at Birth [Time Frame: Approximately 40 weeks of gestational age.]

Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation]

Percentage of Participants With Cord Blood Parasitemia at Delivery [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation]

Percentage of Neonates With LBW (<2500 g) in ITT Population [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation]

Percentage of Participants With Pre-eclampsia From Week 20 to Delivery [Time Frame: From Week 20 to approximately 40 weeks of gestational age]

Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation [Time Frame: At 36-38 weeks of gestation.]

Percentage of Participants With Peripheral Parasitemia at Delivery [Time Frame: Approximately 40 weeks of gestational age]

Percentage of Perinatal or Neonatal Deaths [Time Frame: Day 28 after delivery.]

Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation. [Time Frame: At 36-38 weeks of gestation]

Percentage of Participants With Placental Parasitemia at Delivery [Time Frame: Approximately 40 weeks of gestational age]

Sexually Transmitted Infection (STI) Episodes Per Participant [Time Frame: Approximately 40 weeks of gestational age .]

Secondary ID(s)

A0661158

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

London School of Hygiene and Tropical Medicine

Medicines for Malaria Venture

Results

• Results available: Yes
• Date Posted: 05/09/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01103063