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

Primary Purpose

Malaria in Pregnancy, Sexually Transmitted Infections, Anaemia

Status
Completed
Phase
Phase 3
Locations
Papua New Guinea
Study Type
Interventional
Intervention
chloroquine, sulphadoxine pyrimethamine, LLIN
azithromycin, sulphadoxine pyrimethamine, LLIN
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria in Pregnancy focused on measuring Plasmodium falciparum, Plasmodium vivax, azithromycin, sulphadoxine pyrimethamine, low birth weight, haemoglobin, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum

Eligibility Criteria

16 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Papua New Guinea Institute of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SP, chloroquine treatment; bed net

3 x SP plus azithromycin; bed nets

Arm Description

Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net

Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
From enrolment at 14-26 weeks gestation, until delivery
Incidence of symptomatic malaria during pregnancy
From enrolment at 14-26 weeks until delivery
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
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
Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected 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
Impact of IPTp on development of immunity to malaria in pregnancy
Characteristics of parasites infecting pregnant women

Full Information

First Posted
April 6, 2010
Last Updated
April 20, 2013
Sponsor
University of Melbourne
Collaborators
Papua New Guinea Institute of Medical Research, The University of Western Australia, Walter and Eliza Hall Institute of Medical Research, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01136850
Brief Title
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
Acronym
IPTp in PNG
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
Collaborators
Papua New Guinea Institute of Medical Research, The University of Western Australia, Walter and Eliza Hall Institute of Medical Research, University of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2793 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP, chloroquine treatment; bed net
Arm Type
Active Comparator
Arm Description
Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net
Arm Title
3 x SP plus azithromycin; bed nets
Arm Type
Experimental
Arm Description
Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net.
Intervention Type
Drug
Intervention Name(s)
chloroquine, sulphadoxine pyrimethamine, LLIN
Other Intervention Name(s)
sulfadoxine-pyrimethamine
Intervention Description
> 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.
Intervention Type
Drug
Intervention Name(s)
azithromycin, sulphadoxine pyrimethamine, LLIN
Other Intervention Name(s)
Zithromax, sulfadoxine-pyrimethamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of women delivering low birth weight babies, <2500 g
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology
Time Frame
at delivery
Title
Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl).
Time Frame
At delivery
Title
Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy
Description
From enrolment at 14-26 weeks gestation, until delivery
Time Frame
up to 26 weeks
Title
Incidence of symptomatic malaria during pregnancy
Description
From enrolment at 14-26 weeks until delivery
Time Frame
Up to 26 weeks
Title
Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks).
Time Frame
28-34 week gestation study visit
Title
Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications
Description
From enrolment at 14-26 weeks gestation until delivery
Time Frame
14-26 weeks
Title
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
Title
Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery
Time Frame
at delivery
Title
Maternal, perinatal and infant mortality rates
Description
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
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
Title
Impact of IPTp on development of immunity to malaria in pregnancy
Time Frame
at delivery
Title
Characteristics of parasites infecting pregnant women
Time Frame
Up to 26 weeks, from 14-26 weeks gestation until delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Rogerson, FRACP PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papua New Guinea Institute of Medical Research
City
Madang
State/Province
Madang Province
Country
Papua New Guinea

12. IPD Sharing Statement

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Citation
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Links:
URL
http://mip-consortium.org
Description
home page of umbrella organisation coordinating this and other trials on malaria in pregnancy
URL
http://www.medrmhwh.unimelb.edu.au/
Description
home page of Department of Central contact person, Dr Rogerson
URL
http://www.pngimr.org.pg
Description
home page of Papua New Guinea Institute of Medical Research

Learn more about this trial

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

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