Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea (IPTp in PNG)
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|ClinicalTrials.gov Identifier: NCT01136850|
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malaria in Pregnancy Sexually Transmitted Infections Anaemia||Drug: chloroquine, sulphadoxine pyrimethamine, LLIN Drug: azithromycin, sulphadoxine pyrimethamine, LLIN||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2793 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
Active Comparator: SP, chloroquine treatment; bed net
Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net
Drug: chloroquine, sulphadoxine pyrimethamine, LLIN
> 50Kg: chloroquine base 150 mg 4 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose.
< 50 Kg: chloroquine base 150 mg 3 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose.
Given at enrolment, 14-26 weeks gestation, by mouth.
Other Name: sulfadoxine-pyrimethamine
Experimental: 3 x SP plus azithromycin; bed nets
Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net.
Drug: azithromycin, sulphadoxine pyrimethamine, LLIN
sulphadoxine pyrimethamine (1500 mg/75 mg as single dose) plus azithromycin (1 g twice daily for 2 days).
Given three times by mouth at monthly intervals, commencing at between 14 and 26 weeks gestation.
- Proportion of women delivering low birth weight babies, <2500 g [ Time Frame: At delivery ]
- Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology [ Time Frame: at delivery ]
- Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl). [ Time Frame: At delivery ]
- Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy [ Time Frame: up to 26 weeks ]From enrolment at 14-26 weeks gestation, until delivery
- Incidence of symptomatic malaria during pregnancy [ Time Frame: Up to 26 weeks ]From enrolment at 14-26 weeks until delivery
- Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks). [ Time Frame: 28-34 week gestation study visit ]
- Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications [ Time Frame: 14-26 weeks ]From enrolment at 14-26 weeks gestation until delivery
- Prevalence of drug resistance markers in parasites infecting women in late pregnancy, particularly in the P falciparum and P vivax dihydrofolate reductase and dihydropteroate synthase enzymes, associated with SP resistance [ Time Frame: at delivery ]
- Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery [ Time Frame: at delivery ]
- Maternal, perinatal and infant mortality rates [ Time Frame: Mothers; up to 32 weeks, from enrolment at 14-26 weeks gestation, until delivery. Pernatal: 16 weeks, from 28 weeks gestation to 4 weeks of age. Infant: from live birth to 1 year of age ]maternal mortality is during pregnancy and until 6 weeks post partum. Perinatal mortality is from 28 weeks gestation until 6 weeks postpartum. Infant mortality is from irth to 12 months of age
- Impact of IPTp on development of immunity to malaria in pregnancy [ Time Frame: at delivery ]
- Characteristics of parasites infecting pregnant women [ Time Frame: Up to 26 weeks, from 14-26 weeks gestation until delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136850
|Papua New Guinea|
|Papua New Guinea Institute of Medical Research|
|Madang, Madang Province, Papua New Guinea|
|Principal Investigator:||Stephen J Rogerson, FRACP PhD||University of Melbourne|