Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
Information source: University of Melbourne
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria in Pregnancy; Sexually Transmitted Infections; Anaemia
Intervention: chloroquine, sulphadoxine pyrimethamine, LLIN (Drug); azithromycin, sulphadoxine pyrimethamine, LLIN (Drug)
Phase: Phase 3
Sponsored by: University of Melbourne
Official(s) and/or principal investigator(s):
Stephen J Rogerson, FRACP PhD, Principal Investigator, Affiliation: University of Melbourne
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.
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Proportion of women delivering low birth weight babies, <2500 g
Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology
Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).
Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy
Incidence of symptomatic malaria during pregnancy
Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).
Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications
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
Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery
Maternal, perinatal and infant mortality rates
Impact of IPTp on development of immunity to malaria in pregnancy
Characteristics of parasites infecting pregnant women
Minimum age: 16 Years.
Maximum age: 49 Years.
- 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
- 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
- Known multiple pregnancy
Locations and Contacts
Papua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea
home page of umbrella organisation coordinating this and other trials on malaria in pregnancy
home page of Department of Central contact person, Dr Rogerson
home page of Papua New Guinea Institute of Medical Research
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Starting date: November 2009
Last updated: April 20, 2013