Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea (IPTp in PNG)
|Malaria in Pregnancy Sexually Transmitted Infections Anaemia||Drug: chloroquine, sulphadoxine pyrimethamine, LLIN Drug: azithromycin, sulphadoxine pyrimethamine, LLIN||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
|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|
- 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 ]
|Study Start Date:||November 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|