Clinical trial NCT01136850: Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria in Pregnancy
Sexually Transmitted Infections
Anaemia
Keywords: Plasmodium falciparum
Plasmodium vivax
azithromycin
sulphadoxine pyrimethamine
low birth weight
haemoglobin
Chlamydia trachomatis
Neisseria gonorrhoeae
Treponema pallidum
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Papua New Guinea Institute of Medical Research
name: The University of Western Australia
name: Walter and Eliza Hall Institute of Medical Research
name: University of Barcelona
First posted: 2010-06-04
Enrollment: 2793
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women delivering low birth weight babies, <2500 g
timeFrame: At delivery
Secondary outcomes:
measure: Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology
timeFrame: at delivery
measure: Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).
timeFrame: At delivery
measure: Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy
timeFrame: up to 26 weeks
measure: Incidence of symptomatic malaria during pregnancy
timeFrame: Up to 26 weeks
measure: Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).
timeFrame: 28-34 week gestation study visit
measure: Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications
timeFrame: 14-26 weeks
measure: 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
timeFrame: at delivery
measure: Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery
timeFrame: at delivery
measure: Maternal, perinatal and infant mortality rates
timeFrame: 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
measure: Impact of IPTp on development of immunity to malaria in pregnancy
timeFrame: at delivery
measure: Characteristics of parasites infecting pregnant women
timeFrame: Up to 26 weeks, from 14-26 weeks gestation until delivery
Other outcomes:
Locations:
city: Madang
country: Papua New Guinea
facility: Papua New Guinea Institute of Medical Research
state: Madang Province
Study officials:
affiliation: University of Melbourne
name: Stephen J Rogerson, FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Unger HW, Bleicher A, Ome-Kaius M, Aitken EH, Rogerson SJ. Associations of maternal iron deficiency with malaria infection in a cohort of pregnant Papua New Guinean women. Malar J. 2022 May 26;21(1):153. doi: 10.1186/s12936-022-04177-8.
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