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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201110000321348 Date of Registration: 04/10/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IV ARTESUNATE PLUS ACT Vs IV QUININE PLUS ACT AND EVALUATION OF PHARMACOKINETICS OF ARTEMETHER-LUMEFANTRINE AND DIHYDROARTEMISININ-PIPERAQUINE
Official scientific title INTRAVENOUS ARTESUNATE PLUS ACT Vs INTRAVENOUS QUININE PLUS ACT FOR SEVERE MALARIA TREATMENT IN UGANDAN PATIENTS
Brief summary describing the background and objectives of the trial Artesunate is highly effective, well tolerated and safe. Evidence recommends artesunate in preference to quinine for severe malaria treatment. WHO recommends parenteral treatment for severe malaria for a minimum of 24 hours and once patients can tolerate oral therapy, treatment to be completed with an effective oral antimalarial drug. We will evaluate the efficacy of IV artesunate plus ACT vs IV quinine plus ACT for the treatment of severe malaria and evaluate ACT pharmacokinetics
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPQUACT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 24/10/2011
Actual trial start date 02/01/2012
Anticipated date of last follow up 28/02/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 404
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HS 1031 UGANDA NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY
REC REF 2011-175 MAKERERE UNIVERSITY SCHOOL OF MEDICINE RESEARCH AND ETHICS COMMITEE
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 Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intravenous quinine plus ACT 10mg/kg 8 hourly till patients are able to tolerate oral therapy with ACT parenteral quinine 202 Active-Treatment of Control Group
Experimental Group IV artesunate plus ACT 2.4mg/kg stat then 2.4mg/kg at 12 hours then 2.4mg/kg od till patients are able to tolerate oral therapy with ACT parenteral artesunate 202
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Age 6 months and above 2) With a positive blood smear for P. falciparum asexual parasitaemia with no other cause of the symptoms 3) Who meet the WHO clinical or laboratory criteria for severe malaria requiring parenteral therapy 3) Whose parents/caretakers provide written informed consent and are willing to participate in 42 day follow up 1) Administration of any additional antimalarial drugs that are not study drugs within 72 hours before study enrolment and during the course of the study. 2) Emergence of any non-malarial febrile illness which may interfere with the classification of malaria treatment outcome 3) Movement away from the study area interfering with follow-up assessment 4) Patients with contraindications to taking the study drugs 5) Withdrawal of consent 6 Month(s) 60 Year(s) Both
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 18/07/2011 MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES SCHOOL OF MEDICINE RESEARCH AND ETHICS COMMITTE
Ethics Committee Address
Street address City Postal code Country
MULAGO HOSPITAL COMPLEX, KAMPALA KAMPALA +256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Treatment failure unadjusted by genotyping Day 7, 14, 21, 28, 35 and 42
Secondary Outcome Treatment failure adjusted by genotyping Day 7, 14, 21, 28, 35, and 42
Secondary Outcome Time to event outcomes including: fever and parasite clearance times, coma recovery time, time to begin oral intake and time to sit up unsupported Day 7, 14, 21, 28, 35, and 42
Secondary Outcome Haemoglobin recovery on day 28 Day 7, 14, 21, 28, 35 and 42
Secondary Outcome Adverse events Days 7, 14, 21, 28, 35 and 42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tororo District Hospital Tororo Tororo +256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Laan van Nieuw Oost Indië 334 HAGUE +256 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor INFECTIOUS DISEASES INSTITUTE LTD MULAGO HOSPITAL COMPLEX KAMPALA +256 Uganda University
COLLABORATORS
Name Street address City Postal code Country
NIKLAS LINDEGARDH MAHIDOL UNIVERSITY BANGKOK Thailand
CONCEPTA MERRY MULAGO HOSPITAL COMPLEX KAMPALA +256 Uganda
MOSES KAMYA MULAGO HOSPITAL COMPLEX KAMPALA +256 Uganda
MOHAMMED LAMORDE MULAGO HOSPITAL COMPLEX KAMPALA +256 Uganda
JANE ACHAN MULAGO HOSPITAL COMPLEX KAMPALA +256 Uganda
JOEL TARNING MAHIDOL OXFORD TROPICAL MEDICINE RESEARCH UNIT, FACULTY OF TROPICAL MEDICINE, MAHIDOL MAHIDOL Thailand
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator PAULINE BYAKIKA-KIBWIKA pbyakika@gmail.com +256 772 626885 MULAGO HOSPITAL COMPLEX
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda PI
Role Name Email Phone Street address
Public Enquiries MOHAMMED LAMORDE mlamorde@idi.co.ug +256 772 185590 INFECTIOUS DISEASES INSTITUTE
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda CO-INVESTIGATOR
Role Name Email Phone Street address
Scientific Enquiries JANE ACHAN achanj@yahoo.co.uk +256 772 410183 MULAGO HOSPITAL COMPLEX
City Postal code Country Position/Affiliation
KAMPALA +256 Uganda Co-PI
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