Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea

University of Melbourne2,793 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

2,793

Conditions

Malaria in Pregnancy Sexually Transmitted Infections Anaemia

Interventions

chloroquine, sulphadoxine pyrimethamine, LLINDRUG

\> 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.

azithromycin, sulphadoxine pyrimethamine, LLINDRUG

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.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * pregnant * 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

Locations (1)

Papua New Guinea Institute of Medical Research

Madang, Madang Province, Papua New Guinea

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

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

From enrolment at 14-26 weeks gestation, until delivery

Time frame: up to 26 weeks

Incidence of symptomatic malaria during pregnancy

From enrolment at 14-26 weeks until delivery

Time frame: Up to 26 weeks

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

From enrolment at 14-26 weeks gestation until delivery

Time frame: 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

Time frame: at delivery

Data from ClinicalTrials.gov

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