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.: PACTR201911466695052 Date of Approval: 29/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of a Single dose versus Triple Dose Regimen of Mebendazole against Hookworm infections among School Children: Randomized trial.
Official scientific title Efficacy of a Single dose versus Triple Dose Regimen of Mebendazole against Hookworm infection among School Children: Randomized trial.
Brief summary describing the background and objectives of the trial Hookworm infection is one of the neglected tropical diseases which poses a global disease-burden by infecting over 576 million people around the world and still it remain a public health problem in developing countries.. Majority of hookworm infections are harbored by children and adults. Current control efforts are focused on reducing morbidity and transmission potential through periodic anthelminthic chemotherapy Single dose mebendazole regimen is one of extensively applicable drug regimen as a preventive chemotherapy in hookworm endemic areas. However, nowadays, studies reveal these single dose treatment regimen has poor and unsatisfactory efficacy status against hookworm infection. In this study we assessed and compared the efficacy status of single dose (500mg) and triple dose (100mg) of mebendazole against hookworm infection among school aged children.
Type of trial RCT
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 Hookworm infection
Purpose of the trial Treatment: Drugs
Anticipated trial start date 22/04/2019
Actual trial start date 22/04/2019
Anticipated date of last follow up 12/05/2019
Actual Last follow-up date 03/06/2019
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 103
Recruitment status Completed
Publication URL no yet published
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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mebendazole drug Single dose(500mg) of mebendazole regimen 14-21 days after treatment Eligible hookworm positive children were randomly assigned with (1:1) ration either to the single dose (500mg) or triple dose regimen of mebendazole (100 mg twice a day for three consecutive days) arm of the study. The drug which administered for the study was found in the local market single dose (500mg) (Vermox®) of mebendazole. 54
Control Group mebendazole drug triple dose (100mg) 14-21 days after treatment After eligible hookworm positive children were randomly assigned with (1:1) ration either to the single dose (500mg) or triple dose regimen of mebendazole (100 mg twice a day for three consecutive days) arm of the study The drug which administered for the study was found in the local market triple dose (100 mg twice a day for three consecutive days) (WORMIN tab) of mebendazole. 54 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Written informed consent signed by parents and/or legal guardians; and a verbal assent (children <18 years) according to Ethiopian regulation. • Able and willing to be examined by a study physician at the beginning of the study. • Able and willing to provide required stool samples at the beginning (baseline) and two to three weeks after treatment (follow-up). • Positive for hookworm eggs in the stool. • No recent anthelminthic treatment (within past 4 weeks). • Negative pregnancy test (girls ≥12 years) • Apparently health individual; based on medical history, physical examination, vital signs, hemoglobin level were included • Children who were able to chew the drug were subjected for randomization • Participant had hemoglobin level above 8g/dl • Individual who has taken any form of medication containing mebendazole or any other treatment for STH infection within 30 days of entry into the study • Who had diarrhea at the time of the first sampling, • Who experience a severe concurrent medical condition, • Participant with haemoglobin level below 8g/dl, • Child with known history of allergic reaction to mebendazole, and • Participants infected with other parasitic infection were excluded from the allocated treatment Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 12 Year(s) 14 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 19/04/2019 Ethics Comm School of Biomed and Lab Science Univ Gondar
Ethics Committee Address
Street address City Postal code Country
Gondar, Northwest Ethiopia Gondar 0196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure rate or CR. CR means the proportion of individual hosts positive for parasites who become parasitologically negative after treatment with in 14-21 days after treatment
Secondary Outcome Arithmetic mean of Feacal Egg Reduction Rate OR ERR. ERR is the arithmetic mean egg count at baseline of the treatment group minus mean egg count at the end of treatment period divided by the mean egg count at the baseline and express it in percent. with in 14-21 days after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary school in Burie Town Burie, West Gojjam Burie Ethiopia
Primary school in Debre Elias town Debre Elias, East Gojjam Debre Elias Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Thesis research Grant Nortwest Ethiopia Gondar 0196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Northwest Ethiopia Gondar 0196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Tegegne Eshetu Gondar, Northwest Ethiopia Gondar Ethiopia
Mulugeta Aemero Gondar, Northwest Ethiopia Gondar Ethiopia
Ayalew Jejaw Gondar, Northwest Ethiopia Gondar Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tegegne Eshetu tegegneeshetu5@gmail.com +251921738483 Northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia Lecturer in University of Gondar
Role Name Email Phone Street address
Public Enquiries Mulugeta Aemero bmeskel@gmail.com +25113073815 Gondar, northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia Department head of tropical and infectious diseases University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Ayalew Jejaw ayalewjejaw@gmail.com +251985024932 Gondar, Northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia department head of medical parasitology University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All essential individual participant data was available on the hand of principal investigator (Tegegne Eshetu) and we are willing to share it accordingly if it is needed . Informed Consent Form,Statistical Analysis Plan,Study Protocol It is available for a certain period of time on the hand of principal investigato If legal person is require about additional data of this study, we delight to share it.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet available in web sites 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