Anaemia Clinical Trial
— IPTp in PNGOfficial 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
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.
Status | Completed |
Enrollment | 2793 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 49 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Papua New Guinea | Papua New Guinea Institute of Medical Research | Madang | Madang Province |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne | Papua New Guinea Institute of Medical Research, The University of Western Australia, University of Barcelona, Walter and Eliza Hall Institute of Medical Research |
Papua New Guinea,
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. — View Citation
Benet A, Khong TY, Ura A, Samen R, Lorry K, Mellombo M, Tavul L, Baea K, Rogerson SJ, Cortés A. Placental malaria in women with South-East Asian ovalocytosis. Am J Trop Med Hyg. 2006 Oct;75(4):597-604. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of women delivering low birth weight babies, <2500 g | At delivery | No | |
Secondary | Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology | at delivery | No | |
Secondary | Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl). | At delivery | No | |
Secondary | 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 | up to 26 weeks | No |
Secondary | Incidence of symptomatic malaria during pregnancy | From enrolment at 14-26 weeks until delivery | Up to 26 weeks | No |
Secondary | Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks). | 28-34 week gestation study visit | No | |
Secondary | 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 | 14-26 weeks | Yes |
Secondary | 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 | at delivery | No | |
Secondary | Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery | at delivery | No | |
Secondary | 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 | 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 | No |
Secondary | Impact of IPTp on development of immunity to malaria in pregnancy | at delivery | No | |
Secondary | Characteristics of parasites infecting pregnant women | Up to 26 weeks, from 14-26 weeks gestation until delivery | No |
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