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

Study Overview
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Brief Summary
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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
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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

Conditions
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Malaria in Pregnancy, Sexually Transmitted Infections, Anaemia

Intervention / Treatment
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* Drug: chloroquine, sulphadoxine pyrimethamine, LLIN
* Drug: azithromycin, sulphadoxine pyrimethamine, LLIN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SP, chloroquine treatment; bed net<br>Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net | Drug: chloroquine, sulphadoxine pyrimethamine, LLIN<br>* > 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.<br>* Other names: sulfadoxine-pyrimethamine;|
| Experimental: 3 x SP plus azithromycin; bed nets<br>Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net. | Drug: azithromycin, sulphadoxine pyrimethamine, LLIN<br>* 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.<br>* Other names: sulfadoxine-pyrimethamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women delivering low birth weight babies, <2500 g |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From enrolment at 14-26 weeks gestation, until delivery | up to 26 weeks | 
| Incidence of symptomatic malaria during pregnancy | From enrolment at 14-26 weeks until delivery | 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 | From enrolment at 14-26 weeks gestation until delivery | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasmodium falciparum, Plasmodium vivax, azithromycin, sulphadoxine pyrimethamine, low birth weight, haemoglobin, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum