Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea (IPTp in PNG)

This study has been completed.
Sponsor:
Collaborators:
Papua New Guinea Institute of Medical Research
The University of Western Australia
Walter and Eliza Hall Institute of Medical Research
University of Barcelona
Information provided by (Responsible Party):
Stephen Rogerson, University of Melbourne
ClinicalTrials.gov Identifier:
NCT01136850
First received: April 6, 2010
Last updated: April 20, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Malaria in Pregnancy
Sexually Transmitted Infections
Anaemia
Drug: chloroquine, sulphadoxine pyrimethamine, LLIN
Drug: azithromycin, sulphadoxine pyrimethamine, LLIN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Proportion of women delivering low birth weight babies, <2500 g [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl). [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    From enrolment at 14-26 weeks gestation, until delivery

  • Incidence of symptomatic malaria during pregnancy [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
    From enrolment at 14-26 weeks until delivery

  • Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks). [ Time Frame: 28-34 week gestation study visit ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications [ Time Frame: 14-26 weeks ] [ Designated as safety issue: Yes ]
    From enrolment at 14-26 weeks gestation until delivery

  • 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 ] [ Designated as safety issue: No ]
  • Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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

  • Impact of IPTp on development of immunity to malaria in pregnancy [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Characteristics of parasites infecting pregnant women [ Time Frame: Up to 26 weeks, from 14-26 weeks gestation until delivery ] [ Designated as safety issue: No ]

Enrollment: 2793
Study Start Date: November 2009
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SP, chloroquine treatment; bed net
Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net
Drug: chloroquine, sulphadoxine pyrimethamine, LLIN

> 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 Name: sulfadoxine-pyrimethamine
Experimental: 3 x SP plus azithromycin; bed nets
Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net.
Drug: azithromycin, sulphadoxine pyrimethamine, LLIN

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

  Eligibility

Ages Eligible for Study:   16 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136850

Locations
Papua New Guinea
Papua New Guinea Institute of Medical Research
Madang, Madang Province, Papua New Guinea
Sponsors and Collaborators
University of Melbourne
Papua New Guinea Institute of Medical Research
The University of Western Australia
Walter and Eliza Hall Institute of Medical Research
University of Barcelona
Investigators
Principal Investigator: Stephen J Rogerson, FRACP PhD University of Melbourne
  More Information

Additional Information:
Publications:

Responsible Party: Stephen Rogerson, Professor of Medicine, University of Melbourne
ClinicalTrials.gov Identifier: NCT01136850     History of Changes
Other Study ID Numbers: 70270
Study First Received: April 6, 2010
Last Updated: April 20, 2013
Health Authority: Papua New Guinea: Papua New Guinea Medical Research Advisory Council

Keywords provided by University of Melbourne:
Plasmodium falciparum
Plasmodium vivax
azithromycin
sulphadoxine pyrimethamine
low birth weight
haemoglobin
Chlamydia trachomatis
Neisseria gonorrhoeae
Treponema pallidum

Additional relevant MeSH terms:
Anemia
Malaria
Sexually Transmitted Diseases
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Azithromycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014