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

University of Melbourne1 site in 1 country2,793 target enrollmentNovember 2009

ConditionsMalaria in Pregnancy Sexually Transmitted Infections Anaemia

Interventionschloroquine, sulphadoxine pyrimethamine, LLIN azithromycin, sulphadoxine pyrimethamine, LLIN

Drugschloroquine, sulphadoxine pyrimethamine, LLIN azithromycin, sulphadoxine pyrimethamine, LLIN

Overview

Phase: Phase 3
Intervention: chloroquine, sulphadoxine pyrimethamine, LLIN
Conditions: Malaria in Pregnancy
Sponsor: University of Melbourne
Enrollment: 2793
Locations: 1
Primary Endpoint: Proportion of women delivering low birth weight babies, <2500 g
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

January 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Melbourne

Responsible Party

Principal Investigator

Stephen Rogerson

Professor of Medicine

University of Melbourne

Eligibility Criteria

Inclusion Criteria

•14-26 weeks'gestation
•permanent resident of study area
•exclusive use of study health facilities for primary health care
•Age is between 16 and 49 years

Exclusion Criteria

•Known chronic illness, e.g. TB, diabetes, renal failure
•Severe anaemia requiring hospitalisation (Hb \< 6 g/dl accompanied by symptoms requiring urgent treatment)
•permanent disability, that prevents or impedes study participation and/or comprehension
•Known multiple pregnancy

Arms & Interventions

SP, chloroquine treatment; bed net

Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net

Intervention: chloroquine, sulphadoxine pyrimethamine, LLIN

3 x SP plus azithromycin; bed nets

Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net.

Intervention: azithromycin, sulphadoxine pyrimethamine, LLIN

Outcomes

Primary Outcomes

Proportion of women delivering low birth weight babies, <2500 g

Time Frame: At delivery

Secondary Outcomes

Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology(at delivery)
Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).(At delivery)
Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy(up to 26 weeks)
Incidence of symptomatic malaria during pregnancy(Up to 26 weeks)
Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).(28-34 week gestation study visit)
Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications(14-26 weeks)
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(at delivery)
Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery(at delivery)
Maternal, perinatal and infant mortality rates(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)
Impact of IPTp on development of immunity to malaria in pregnancy(at delivery)
Characteristics of parasites infecting pregnant women(Up to 26 weeks, from 14-26 weeks gestation until delivery)