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

• Register: EUCTR
• Last refreshed on: 13 April 2015
• Main ID: EUCTR2014-004952-80-Outside-EU/EEA
• Date of registration: 03/04/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc
• 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: 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
• Target sample size: 2891
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004952-80
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Benin, Kenya, Malawi, Tanzania, United Republic of, Uganda

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Intermittent Preventive Treatment In Pregnancy (IPTp)
MedDRA version: 17.1 Level: PT Classification code 10025487 Term: Malaria System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Product Name: azithromycin and chloroquine
Product Code: PF-06425116
Pharmaceutical Form: Tablet
INN or Proposed INN: azithromycin
CAS Number: 83905-01-5
Current Sponsor code: PF-06425116
Other descriptive name: AZITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
INN or Proposed INN: CHLOROQUINE
CAS Number: 54-05-7
Current Sponsor code: PF-06425116
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 155-

Trade Name: Fansidar
Pharmaceutical Form: Tablet
INN or Proposed INN: SULFADOXINE
CAS Number: 2447-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: PYRIMETHAMINE BITARTRATE
Other descriptive name: Fansidar
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Secondary Objective: Proportion of subjects with Low birth weight (LBW) (less than [<] 2500 gram [g]) live neonates.
Proportion of subjects with severe anemia (hemoglobin <8 gram per decilitre [g/dL]).
Proportion of subjects with anemia (hemoglobin <11 g/dL).
Proportion of subjects with placental parasitemia.
Occurrence of Sexually transmitted infections (STIs).
Safety and tolerability of the 2 treatment regimens.
Presence of subjects with a sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500 g), premature birth (<37 weeks), abortion (less than or equal to [<=] 28 weeks), still birth (greater than [>] 28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.

Main Objective: To establish superiority of Azithromycin/chloroquine (AZCQ) over Sulfadoxine-pyrimethamine (SP) in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

Timepoint(s) of evaluation of this end point: Approximately 40 weeks of gestational age

Primary end point(s): Percentage Subjects With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population

Secondary Outcome(s)

Secondary end point(s): 1) At 40 Weeks Gestational Age
-Percentage of Subjects With Sub-optimal Pregnancy Outcome in Efficacy Analysable Per Protocol (PP) Population
-Percentage of Neonates With LBW (<2500 g) in ITT Population
-Percentage of Neonates With LBW (<2500 g) in Efficacy Analysable PP Population
-Percentage of Subjects With Placental Parasitemia at Delivery
-Percentage of Subjects With Placental Malaria at Delivery Based on Histology
-Sexually Transmitted Infection (STI) Episodes Per Subject
-Percentage of Subjects With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
-Percentage of Neonates With Congenital Abnormalities at Birth
-Birth Weight of Live Borne Neonate
-Number of Episodes of Symptomatic Malaria Per Subject From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
-Percentage of Subjects Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
-Percentage of Subjects With Peripheral Parasitemia at Delivery
-Percentage of Subjects With Cord Blood Parasitemia at Delivery
-Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
-Percentage of Subjects With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
2)Visits 6 and 7
-Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
-Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
3) Week 20 to week 40
- Percentage of Subjects With Pre-eclampsia From Week 20 to Delivery
4)At 36-38 weeks of gestation
-Percentage of Subjects With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
-Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration
-Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
-Percentage of Subjects With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
-Percentage of Subjects With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
-Percentage of Subjects With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
-Percentage of Subjects With Treponema Pallidum Infection at 36-38 Weeks of Gestation
-Percentage of Subjects With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
-Percentage of Subjects With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation
5) Day 28 after delivery
-Percentage of Perinatal or Neonatal Deaths

Timepoint(s) of evaluation of this end point: 1) Approximately 40 weeks of gestational age
2)Visits 6 and 7
3) From Week 20 to approximately 40 weeks of gestational age
4) At and up to 36-38 weeks of gestation
5) Day 28 after delivery

Secondary ID(s)

NCT01103063

A0661158

Source(s) of Monetary Support

Pfizer Inc.