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

University of Melbourne

Status and phase: Completed; Phase 3

Conditions: Sexually Transmitted Infections; Anaemia; Malaria in Pregnancy

Treatments: Drug: chloroquine, sulphadoxine pyrimethamine, LLIN; Drug: azithromycin, sulphadoxine pyrimethamine, LLIN

Study type: Interventional

Funder types: Other

Identifiers

NCT01136850

70270

Details and patient eligibility

About

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.

Enrollment: 2,793 patients

Sex: Female

Ages: 16 to 49 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,793 participants in 2 patient groups

SP, chloroquine treatment; bed net

Active Comparator group

Description:

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

Treatment:

Drug: chloroquine, sulphadoxine pyrimethamine, LLIN

3 x SP plus azithromycin; bed nets

Experimental group

Description:

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

Treatment:

Drug: azithromycin, sulphadoxine pyrimethamine, LLIN