Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010020001862624 Date of Approval: 21/01/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ACT IN PREGNANT WOMEN
Official scientific title Comparison of the safety, efficacy and tolerability of artemether¬-lumefantrine and artesunate amodiaquine in Nigerian pregnant women with acute uncomplicated falciparum malaria
Brief summary describing the background and objectives of the trial In many regions of the world, Nigeria inclusive, malaria parasites have become unresponsive to conventional anti-malarial drugs. Drug efficacy trials in the six geopolitical regions of the country in 2002-2004 indicated that chloroquine and Sulphadoxine-pyrimethamine were no longer adequate for national first line use. Artemisin based combination therapy were found to be highly efficacious. The FMOH now recommends artemether-lumefantrine and artesunate amodiaquine for use in pregnancy. There is
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2010
Actual trial start date
Anticipated date of last follow up 02/02/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ERC/2012/12/09 Research and Ethics Committee Obafemi Awolowo University Teaching Hospitals Complex.
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation in blocks of 10 Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation in blocks of 10 Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Computer generated randomization sequence Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated randomization sequence Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated randomization sequence Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group artesunate-amodiaquine One tablet of artesunate/amodiaquine,100mg/270mg twice daily 3 days 75
Control Group artemether-lumefantrine One tablets of artemether-lumefantrine (Gloatem forte) consisting of 80mg artemether and 480mg lumefantrine 12 hourly Three days 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a)Microscopically-confirmed P. falciparum malaria with parasitaemia of atleast one plus(1-10 parasites /100 thick film field). b)Fever (T of 37.50C) or a history of fever,headaches,body pains within 24 hours of presentation c)Ability to give informed consent d)Willingness/ability to comply with follow up visits. a)Severe malaria or danger signs of severe malaria (e.g. loss of consciousness, convulsions, anuria) b)Women in the first 13 weeks of pregnancy i.e. 1st trimester c)Use of any anti-malarial drug other than sulphadoxine pyrimethamine less than 7 days before presentation d)Other chronic illness e.g. hypertension, sickle cell. e)Other pregnancy related diseases e.g. eclampsia, antepartum hemorrhage f)History of reaction to any of the study drugs g)Patients not tolerating orally. 18 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/11/2012 Research and ethics committee of the Obafemi Awolowo University Teaching Hospitals Complex
Ethics Committee Address
Street address City Postal code Country
OAUTHC Ile-Ife Ile-Ife 220282 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the efficacy, safety and tolerability of Artesunate-Amodiaquine fixed dose combination compared to the Artemether-Lumefantrine fixed dose combination in the treatment of acute uncomplicated P. falciparum malaria in pregnancy. Day 1 Day 3 Day 7 Day 28
Secondary Outcome Describe the pregnancy outcome in these women At 40 weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
adeoyo maternity centre adeoyo maternity centre ibadan Nigeria
Obafemi Awolowo University teaching Hospitals Complex Ile-Ife Ile-Ife 220282 Nigeria
Obafemi Awolowo University teaching Hospitals Complex Wesley Guild Hospital Ilesa Ilesa Ilesa Nigeria
university college hospital ibadan university college hospital ibadan ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Research grant Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife 220282 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Marcel Ukah Dept of Obs & Gynae OAUTHC Ile-Ife Ile-Ife 220282 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Segun Badejoko Dept. of Obs & Gynae OAUTHC Ile-Ife 220282 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marcel Ukah panyvinous@yahoo.com +2347030497456 Dept. of Obs & Gynae OAUTHC Ile-Ife
City Postal code Country Position/Affiliation
Ile-Ife 220282 Nigeria
Role Name Email Phone Street address
Public Enquiries Marcel Ukah panyvinous@yahoo.com +2347030497456 Dept. of Obs & Gynae OAUTHC Ile-Ife
City Postal code Country Position/Affiliation
Ile-Ife 220282 Nigeria
Role Name Email Phone Street address
Scientific Enquiries Marcel Ukah panyvinous@yahoo.com +2347030497456 Dept. of Obs & Gynae OAUTHC Ile-Ife
City Postal code Country Position/Affiliation
Ile-Ife 220282 Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information