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.: PACTR201710002665193 Date of Approval: 04/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ARTEGO STUDY
Official scientific title Comparison Of The Efficacy Bioavailability, Safety Profile And Toxicity Of Artemisinin-Naphtoquinine-Primaquine (ArteGo) And Artemether ¿Lumefantrine In treatment of uncomplicated malaria in Lagos, Nigeria
Brief summary describing the background and objectives of the trial This is a randomized clinical trial for the treatment of uncomplicated malaria comparing the efficacy of Artemisinine/Naphtoquine/Primaquine(ANP) with the standard treatment using Artemether/Lumefanthrine (COARTEM) combination. The objectives are to show that ANP is not inferior to COARTEM in the treatment of malaria and also to look at the effectiveness of low dose Primaquine in reducing transmission rate sine it destrys the gametocytes of the parasite.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARTEGO
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 06/11/2017
Actual trial start date
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Not yet recruiting
Publication URL
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artemisinine/Naphtoquine/Primaquine based on weight 24 hours initial adult dose of 4 tblets followed by 2 tablets 8hours later. Children doses are based on weight 80
Control Group COARTEM GROUP 40/480 TWICW DAILY FOR 3 DAYS. CHILDREN BASED ON WEIGHT 3 DAYS 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Clinical symptoms of malaria such as fever etc. age group: above 6 and below 60 years of age, male and female. Plasmodium falciparum asexual forms ¿ 500/¿L observed in peripheral blood smear; Have not been treated with any antimalarial Written informed consent, in accordance with local practice, provided by patient, for children it will provided by either parents or legal representative and in addition children will provide assent. Body weight between 20 kg and 90 kg (both inclusive) Presence of mono-infection with P. falciparum Ability to swallow oral medication Ability and willingness to adhere to all study procedures and access health facilities. Willing to undergo study related procedures including being hospitalized for minimum of 4 nights), and a follow up of up to 28 days. Age group below 6 or above 60 years Pregnant women Patients with signs and symptoms of severe/complicated malaria as described in the WHO guideline(Third Edition 2012) for management of severe malaria Mixed Plasmodial infection. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment. Severe diarrhoea defined as 3 or more watery stools per day. Presence of other serious or chronic clinical condition requiring hospitalization. Known history or evidence of clinically significant disorders such as cardiovascular, respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological, neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including head trauma). Family history of sudden death or of congenital prolongation of the QT interval or any other clinical condition known to prolong the QT interval. 6 Year(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
No 06/10/2017 LASUTH RHEC
Ethics Committee Address
Street address City Postal code Country
Lagos State University Teaching Hospital Lagos Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Artemisiine/Naphtoquine/Primauine is effective int the treatment of uncomplicated P. falciparum infection defervescence time Parasite clearance time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital,Badagry badagry Badagry town Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
KINGSGLAIVE CONSULTANTS, 42, Ajose Street, Maryland, Lagos State Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KINGSGLAIVE CONSULTANTS, 42, Ajose Street, Maryland, Lagos State Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr . Yemitan Omoniyi Department of Pharmacology,Therapeutics and Toxicology Lagos State University College of Medicine Ikeja 21266 Nigeria
Dr. Rotimi Oladapo Covenant University Otta Ogun State Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bamidele Mutiu drmutiu@yahoo.com 08033565529 LASUTH 1-5 Oba Akinjobi way Ikeja
City Postal code Country Position/Affiliation
Lagos 21266 Nigeria Lecturer/Consultant Microbiologist LASUCOM/LASUTH Ikeja
Role Name Email Phone Street address
Public Enquiries Omoniyi Yemitan kayodeyemitan@gmail.com 08023056011 LASUCOM, Oba Akinjobi way Ikeja
City Postal code Country Position/Affiliation
Lagos 21266 Nigeria
Role Name Email Phone Street address
Scientific Enquiries afolabi Obe obelux246@gmail.com 08032470420 Medical Microbiology LASUTH IKEJA Oba Akinjobi way
City Postal code Country Position/Affiliation
Lagos 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