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

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ClinicalTrials.gov Identifier: NCT01136850
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2793 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2009
Primary Completion Date : December 2012
Study Completion Date : January 2013

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Proportion of women delivering low birth weight babies, <2500 g [ Time Frame: At delivery ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136850

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
Principal Investigator: Stephen J Rogerson, FRACP PhD University of Melbourne
More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Rogerson, Professor of Medicine, University of Melbourne
ClinicalTrials.gov Identifier: NCT01136850     History of Changes
Other Study ID Numbers: 70270
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Hematologic Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Chloroquine diphosphate
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents
Folic Acid Antagonists
Enzyme Inhibitors