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

Information source: University of Melbourne
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria in Pregnancy; Sexually Transmitted Infections; Anaemia

Intervention: chloroquine, sulphadoxine pyrimethamine, LLIN (Drug); azithromycin, sulphadoxine pyrimethamine, LLIN (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Melbourne

Official(s) and/or principal investigator(s):
Stephen J Rogerson, FRACP PhD, Principal Investigator, Affiliation: University of Melbourne

Overall contact:
Stephen J Rogerson, FRACP PhD, Phone: +61 3 83443259, Email: sroger@unimelb.edu.au

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.

Clinical Details

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

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

Secondary outcome:

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

Incidence of symptomatic malaria during pregnancy

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

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

Impact of IPTp on development of immunity to malaria in pregnancy

Characteristics of parasites infecting pregnant women

Eligibility

Minimum age: 16 Years. Maximum age: 49 Years. Gender(s): Female.

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

Locations and Contacts

Stephen J Rogerson, FRACP PhD, Phone: +61 3 83443259, Email: sroger@unimelb.edu.au

Papua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea; Recruiting
Sarah Hanieh, MBBS, Email: managaba@hotmail.com
Ivo Mueller, PhD, Phone: +675 732 2800, Email: ivomueller@fastmail.fm
Sarah Hanieh, MBBS, Sub-Investigator
Additional Information

home page of umbrella organisation coordinating this and other trials on malaria in pregnancy

home page of Department of Central contact person, Dr Rogerson

home page of Papua New Guinea Institute of Medical Research

Related publications:

Steketee RW, Nahlen BL, Parise ME, Menendez C. The burden of malaria in pregnancy in malaria-endemic areas. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):28-35. Review.

Guyatt HL, Snow RW. The epidemiology and burden of Plasmodium falciparum-related anemia among pregnant women in sub-Saharan Africa. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):36-44. Review.

Brabin B, Piper C. Anaemia- and malaria-attributable low birthweight in two populations in Papua New Guinea. Ann Hum Biol. 1997 Nov-Dec;24(6):547-55.

Benet A, Khong TY, Ura A, Samen R, Lorry K, Mellombo M, Tavul L, Baea K, Rogerson SJ, Cort├ęs A. Placental malaria in women with South-East Asian ovalocytosis. Am J Trop Med Hyg. 2006 Oct;75(4):597-604.

Allen SJ, Raiko A, O'Donnell A, Alexander ND, Clegg JB. Causes of preterm delivery and intrauterine growth retardation in a malaria endemic region of Papua New Guinea. Arch Dis Child Fetal Neonatal Ed. 1998 Sep;79(2):F135-40.

Schultz LJ, Steketee RW, Macheso A, Kazembe P, Chitsulo L, Wirima JJ. The efficacy of antimalarial regimens containing sulfadoxine-pyrimethamine and/or chloroquine in preventing peripheral and placental Plasmodium falciparum infection among pregnant women in Malawi. Am J Trop Med Hyg. 1994 Nov;51(5):515-22.

Parise ME, Ayisi JG, Nahlen BL, Schultz LJ, Roberts JM, Misore A, Muga R, Oloo AJ, Steketee RW. Efficacy of sulfadoxine-pyrimethamine for prevention of placental malaria in an area of Kenya with a high prevalence of malaria and human immunodeficiency virus infection. Am J Trop Med Hyg. 1998 Nov;59(5):813-22.

Verhoeff FH, Brabin BJ, Chimsuku L, Kazembe P, Russell WB, Broadhead RL. An evaluation of the effects of intermittent sulfadoxine-pyrimethamine treatment in pregnancy on parasite clearance and risk of low birthweight in rural Malawi. Ann Trop Med Parasitol. 1998 Mar;92(2):141-50.

Shulman CE, Dorman EK, Cutts F, Kawuondo K, Bulmer JN, Peshu N, Marsh K. Intermittent sulphadoxine-pyrimethamine to prevent severe anaemia secondary to malaria in pregnancy: a randomised placebo-controlled trial. Lancet. 1999 Feb 20;353(9153):632-6.

Casey GJ, Ginny M, Uranoli M, Mueller I, Reeder JC, Genton B, Cowman AF. Molecular analysis of Plasmodium falciparum from drug treatment failure patients in Papua New Guinea. Am J Trop Med Hyg. 2004 Mar;70(3):251-5.

ter Kuile FO, van Eijk AM, Filler SJ. Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review. JAMA. 2007 Jun 20;297(23):2603-16. Review.

Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS ONE. 2007 Nov 14;2(11):e1166.

Starting date: November 2009
Last updated: July 21, 2010

Page last updated: February 07, 2013

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