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Completed

NCT Number: NCT01136850

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

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.

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Key information

Conditions

Malaria in Pregnancy Anaemia Anemia Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Genital Diseases Gram-Negative Bacterial Infections Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria Malaria, Falciparum Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Sexually Transmitted Diseases Sexually Transmitted Infections Spirochaetales Infections Treponemal Infections Urogenital Diseases Vector Borne Diseases

Age range

16 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Papua New Guinea Institute of Medical Research

Madang, Madang Province, Papua New Guinea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chloroquine, sulphadoxine pyrimethamine, LLIN

Drug

> 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.

Other names: sulfadoxine-pyrimethamine

azithromycin, sulphadoxine pyrimethamine, LLIN

Drug

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.

Other names: Zithromax, sulfadoxine-pyrimethamine

Primary outcomes

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

    Time frame: At delivery

Secondary outcomes

  1. Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology

    Time frame: at delivery

  2. Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).

    Time frame: At delivery

  3. Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy

    Time frame: up to 26 weeks

    From enrolment at 14-26 weeks gestation, until delivery

  4. Incidence of symptomatic malaria during pregnancy

    Time frame: Up to 26 weeks

    From enrolment at 14-26 weeks until delivery

  5. Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).

    Time frame: 28-34 week gestation study visit

  6. Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications

    Time frame: 14-26 weeks

    From enrolment at 14-26 weeks gestation until delivery

  7. 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

  8. Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery

    Time frame: at delivery

  9. Maternal, perinatal and infant mortality rates

    Time frame: 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

    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

  10. Impact of IPTp on development of immunity to malaria in pregnancy

    Time frame: at delivery

  11. Characteristics of parasites infecting pregnant women

    Time frame: Up to 26 weeks, from 14-26 weeks gestation until delivery

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • Papua New Guinea Institute of Medical Research
  • The University of Western Australia
  • University of Barcelona
  • Walter and Eliza Hall Institute of Medical Research

Registry information

Official study 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

Acronym: IPTp in PNG

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 4, 2010
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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