Condition category
Infections and Infestations
Date applied
04/10/2006
Date assigned
05/10/2006
Last edited
06/10/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olumide Ogundahunsi

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A60044 (MAL IRM 06 02)

Study information

Scientific title

Acronym

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

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

Study design

Open labelled randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Artemether-lumefantrine

Primary outcome measures

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 trial start date

12/02/2007

Overall trial end date

30/09/2009

Reason abandoned

Objectives no longer viable/Lack of sponsorship

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

1664

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

Uganda

Trial 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

Organisation

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

Sponsor details

World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 22 791 2111
mimtdr@who.int

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

Multilateral Initiative on Malaria (MIM)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes