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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2891 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intermittent Preventive Treatment In Pregnancy (IPTp)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AZCQ

Azithromycin/chloroquine

Group Type EXPERIMENTAL

Azithromycin plus chloroquine

Intervention Type DRUG

combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.

SP

sulfadoxine-pyrimethamine (Fansidar)

Group Type ACTIVE_COMPARATOR

sulfadoxine-pyrimethamine

Intervention Type DRUG

Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.

Interventions

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Azithromycin plus chloroquine

combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.

Intervention Type DRUG

sulfadoxine-pyrimethamine

Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.

Intervention Type DRUG

Other Intervention Names

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Fansidar

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes