Safety and efficacy of artemether-lumefantrine therapy for Intermittent Preventive Treatment in pregnancy in Uganda

ISRCTN	ISRCTN12394097
DOI	https://doi.org/10.1186/ISRCTN12394097
Secondary identifying numbers	A60044 (MAL IRM 06 02)

Submission date: 04/10/2006
Registration date: 05/10/2006
Last edited: 06/10/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Olumide Ogundahunsi
Scientific

Implementation Research and Methods (IRM)/Special Programme for Research and Training in Tropical Diseases (TDR)/Centre for Communicable Diseases (CDS)
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)22 791 3597
Email	ogundahunsio@who.int

Study information

Study design	Open labelled randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	In areas where there is high documented case management resistance to Sulfadoxine-Pyramethamine (SP), artemether-lumefantrine if used for Intermittent Preventive Treatment in pregnancy (IPTp) and given to pregnant women between a gestation of 20 weeks and 28 weeks is more efficacious than SP and can decrease by 85% associated placental malaria infection. The aims of this trial are: 1. To assess the efficacy of the use of artemether-lumefantrine as IPTp compared with the use of SP for IPTp on the reduction of prevalence of placental parasitaemia at delivery amongst pregnant women 2. To assess the efficacy of the use of artemether-lumefantrine as IPTp in pregnancy compared with the use of SP for IPTp on reduction of Low Birth Weight (LBW), peripheral parasiteamia, anaemia at 34 weeks and at delivery and decrease in clinical episodes of malaria 3. To assess the safety and tolerability of artemether-lumefantrine as IPTp in pregnancy 4. To determine the prevalence of molecular markers of resistance to SP and artemether-lumefantrine amongst pregnant women 5. To assess the health status of mothers and growth development in babies up to one year after delivery
Ethics approval(s)	Ethics approval received from: 1. Institutional Review and Ethical Board of St Raphael of St. Francis Hospital, Nsambya P.O. Box 7146 Kampala, Uganda 2. Uganda National Council for Science and Technology .P.O. Box 6884 Kampala, Uganda 3. World Health Organization Headquarters Ethics Review Committee, Geneva
Condition	Malaria in pregnancy
Intervention	Study Arm A: Artemether-lumefantrine given as four tablets twice daily for three days for each IPTp dose three times during the pregnancy Study Arm B: Sulphadoxine-pyrimethamine given as three tablets for one day for each IPTp dose three times during the pregnancy. Each dose for each arm will be repeated after 28 days. The Principal Investigator for this trial: Dr Romano Nkumbwa Byaruhanga St. Raphael of St. Francis Hospital Nsambya P.O.Box 7146 Kampala Uganda Telephone: 256-41-267012/3 Email: byaru-rn@africaonline.co.ug Please note, as of 24/09/2009 this trial was stopped by the sponsor (WHO) as monitoring of the trial was not adequate.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artemether-lumefantrine
Primary outcome measure	Prevalence and severity of placental parasitaemia at delivery
Secondary outcome measures	1. Prevalence of low birth weight (less than 2500 g) at delivery 2. Prevalence and severity of peripheral parasitaemia during pregnancy until delivery 3. Prevalence of anaemia (haemoglobin less than 10 g/dl) at 34 weeks and at delivery
Overall study start date	12/02/2007
Overall study end date	30/09/2009
Reason abandoned (if study stopped)	Objectives no longer viable/Lack of sponsorship

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	1664
Participant inclusion criteria	1. Pregnant with a gestational age between 20 to 28 weeks 2. Residing within a radius of 20 miles from the hospital 3. Attending AnteNatal Clinic (ANC) and has not yet received regular programme IPTp with SP 4. Attending ANC and last received anti-malarial treatment greater than one month ago 5. Gives informed consent for study participation 6. Able to come for follow-up
Participant exclusion criteria	1. Known allergy to SP or artemether-lumefantrine 2. Previously diagnosed with Glucose-6-phosphate dehydrogenase deficiency 3. Presently ill with a medical condition requiring admission to hospital 4. Known patient with cardiac disease or arrhythmia 5. Intrauterine foetal death in the current pregnancy
Recruitment start date	12/02/2007
Recruitment end date	30/09/2009

Locations

Countries of recruitment

Switzerland
Uganda

Study participating centre

Implementation Research and Methods (IRM)/Special Programme for Research and Training in Tropical Diseases (TDR)/Centre for Communicable Diseases (CDS)

Geneva-27
CH 1211
Switzerland

Sponsor information

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation

World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 22 791 2111
Email	mimtdr@who.int
Website	http://www.who.int
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

Multilateral Initiative on Malaria (MIM)

No information available

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan