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.: PACTR201905783261453 Date of Approval: 24/05/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and parasite clearance time with artemether-lumefantrine for uncomplicated falciparum malaria in children of Nchelenge District, Zambia
Official scientific title Efficacy and parasite clearance time with artemether-lumefantrine for uncomplicated falciparum malaria in children of Nchelenge District, Zambia
Brief summary describing the background and objectives of the trial Zambia was one of the first countries in Africa to adopt artemether-lumefantrine (AL) in 2002 as its first line treatment for malaria. While efficacy rates remain high with this treatment, there are anecdotal reports of delayed clearance of parasites after treatment with AL in Zambia. There is therefore need to assess the continued efficacy of AL and document whether or not some patients are experiencing delay in clearance of parasites despite adequate treatment with authentic AL. The objective is to assess the parasite clearance time after use of AL for the treatment of uncomplicated P. falciparum infections in children.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
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 14/12/2014
Actual trial start date 14/12/2014
Anticipated date of last follow up 08/08/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
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 Non-randomised 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 Artemether Lumefantrine Half of a dispensable tablet (20 mg of artemether and 120 mg of lumefantrine) per every 5 kg of body weight in a 6-dose regimen over three days. The correct drug dosage will be determined from the dosing chart (Appendix 3). 3 days (6 doses) Antimalarial drug, first line standard of care for uncomplicated falciparum malaria 100
Control Group Artemether Lumefantrine Same as above. This was a single arm efficacy study. Same as above. This was a single arm efficacy study. 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 6 months and 5 years (i.e. up to 59 months of age) Mono-infection with P. falciparum detected by microscopy Parasitaemia of 2,000 to 200,000 /μl asexual forms Presence of axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C, or history of Ability to swallow oral medication Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule Written informed consent from a parent or guardian Presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO as adapted to the clinic setting Mixed or mono-infection with another Plasmodium species detected by microscopy Presence of severe malnutrition defined as a child whose growth (wt for age) is below –3 Z-score Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS) Regular medication, which may interfere with antimalarial pharmacokinetics History of hypersensitivity reactions or contraindications to artemether-lumefantrine Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 14/10/2014 Ministry of Health of the Government of the Republic of Zambia
Ethics Committee Address
Street address City Postal code Country
Ndeke House PO Box 30205 Lusaka 00000 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Therapeutic response 35 days
Secondary Outcome Parasite clearance 0-72 hours
Secondary Outcome Parasite drug resistance genotype 0 and at the time of recurrent parasitemia
Secondary Outcome Lumefantrine pharmacokinetics Day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kabuta Rural Health Centre Mansa Road Nchelenge Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 5601 Fishers Lane Rockville 20852 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Macha Research Trust Macha Mission Hospital Macha Zambia Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Johns Hopkins University 600 N Wolfe St Rm 211 Baltimore 21205 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Philip Thuma phil.thuma@macharesearch.org +17178024519 Macha Research Trust
City Postal code Country Position/Affiliation
Macha Zambia Senior Scientific Director
Role Name Email Phone Street address
Public Enquiries Philip Thuma phil.thuma@macharesearch.org +17178024519 Macha Research Trust
City Postal code Country Position/Affiliation
Macha Zambia Senior Scientific Director
Role Name Email Phone Street address
Scientific Enquiries Philip Thuma phil.thuma@macharesearch.org +17178024519 Macha Research Trust
City Postal code Country Position/Affiliation
Macha Zambia Senior Scientific Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be shared via the WWARN parasite clearance database Study Protocol Within 1 year of publication of final results Access to data will be provided by the authors upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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