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.: PACTR201310000484185 Date of Approval: 15/01/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ARTEMETHER-LUMEFANTRINE VERSUS ARTESUNATE- AMODIAQUINE IN PREGNANT WOMEN
Official scientific title Artemether-lumefantrine versus Artesunate-amodiaquine for treatment of uncomplicated plasmodium falciparum malaria in pregnancy; A randomized control trial.
Brief summary describing the background and objectives of the trial Malaria in pregnancy is a major public health problem which has continued to result in high morbidity and mortality globally, particularly in Sub-Saharan Africa.This trial is to assess the efficacy, safety and tolerability of Artesunate-Amodiaquine combination compared to the Artemether-Lumefantrine fixed dose combination,and also compare the proportion of subjects with parasite clearance by day 3, persistent parasitaemia on day 28,interval to symptomatic relief,side effects between both group.
Type of trial RCT
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 17/01/2013
Actual trial start date 24/01/2013
Anticipated date of last follow up 30/04/2013
Actual Last follow-up date 27/07/2013
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Completed
Publication URL www.journals.elsevier.com/inte
Secondary Ids Issuing authority/Trial register
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artesunate/amodiaquine One tablet of artesunate/amodiaquine containing 100mg artesunate and 270mg amodiaquine 12 hourly 12 hourly Three days 75
Control Group Artemether/lumefantrine One tablet of artemether/lumefantrine (Gloatem forte) containing 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
1.Symptoms of malaria such as fever (T 37.5oc), headaches, body pains within 24 hours before presentation. 2.Microscopically-confirmed P. falciparum malaria with parasitaemia of at least one plus (1-10 parasites/100 thick film field). 3.Consent to participate in the study 4.Willingness/ability to comply with follow-up schedule 1.Severe malaria or danger signs of severe malaria (e.g. loss of consciousness, convulsions, anuria) 2.Women in the first trimester of pregnancy 3.Use of any anti-malarial drug other than sulphadoxine pyrimethamine less than 7 days before presentation 4.Other concurrent pregnancy related diseases e.g. urinary tract infections. 5.History of reaction to any of the drugs. 6.Patients not tolerating orally. 18 Year(s) 49 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 OAUTHC ethical committee
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo university teaching hospitals complex Ile-Ife 220282 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.To compare the efficacy of the artemether/lumefantrine and artesunate amodiaquine fixed dose combinations in pregnant women with acute uncomplicated falciparum malaria day1,day3.day7,day28
Secondary Outcome To assess the pregnancy outcome in these women At 40 weeks of gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo university teaching hospitals complex Ile-Ife Obafemi Awolowo university teaching hospitals complex Ile-Ife Ile-Ife 220282 Nigeria
Wesley guild hospital Ilesa Wesley guild hospital Ilesa Ilesa Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obafemi Awolowo university teaching hospitals complex Obafemi Awolowo university teaching hospitals complex Ile-Ife Ile-Ife 220282 Nigeria
Ukah C M Obafemi Awolowo university teaching hospitals complex Ile-Ife Ile-Ife 220282 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ukah Chukwuemeka Marcel dept of Obs & Gynae OAUTHC Ile-Ife 220282 Nigeria Charities/Societies/Foundation
Secondary Sponsor Obafemi Awolowo university teaching hospitals complex Obafemi Awolowo university teaching hospitals complex 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 Obafemi Awolowo university teaching hospitals complex
City Postal code Country Position/Affiliation
Ile-Ife 220282 Nigeria
Role Name Email Phone Street address
Public Enquiries Marcel Ukah panyvinous@yahoo.com +2347030497456 Obafemi Awolowo university teaching hospitals complex
City Postal code Country Position/Affiliation
Ile-Ife 220282 Nigeria
Role Name Email Phone Street address
Scientific Enquiries Marcel Ukah panyvinous@yahoo.com +2347030497456 Obafemi Awolowo university teaching hospitals complex
City Postal code Country Position/Affiliation
Ile-Ife 220282 Nigeria
REPORTING
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