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.: PACTR202010511829332 Date of Approval: 26/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title In vivo and in vitro anti-hookworm effect of Single dose of Albendazole among outpatients at Adet primary Hospital, Northwest, Ethiopia
Official scientific title In vivo and in vitro anti-hookworm effect of Single dose of Albendazole among outpatients at Adet primary Hospital, Northwest, Ethiopia
Brief summary describing the background and objectives of the trial Hookworm is a soil-transmitted helminths infection associated with rural poverty that infects more than 740 million people worldwide, 200 million of which reside in Sub-Saharan Africa. Since then, albendazole has been widely used across sub-Saharan Africa to treat hookworm infection. Thus, it becomes pertinent to monitor drug efficacy in order to assess the emergence of resistance. In this study, we intend to assess in vivo and in vitro assessment of the anti-hookworm effect of a single dose of Albendazole and associated risk factors among outpatients at Adet primary Hospital, Northwest Ethiopia
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 infections
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2020
Actual trial start date 01/02/2021
Anticipated date of last follow up 30/03/2021
Actual Last follow-up date 21/03/2021
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 70
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Albendazole Efficacy Single-dose(500mg) one time in vivo efficacy assessment of a single-dose of albendazole and in-vitro assessment of the minimum inhibitory concentration of albendazole 70
Control Group albendazole efficacy Single-dose (400mg) one time invitro assessment of a single dose of albendazole and in vivo assessment of a minimum inhibitory concentration of albendazole 70 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 All outpatients agree to comply with study procedures, including the provision of two enough stool samples at the beginning (baseline) and at post-treatment follow up assessments (approximately 2 weeks, later).  All hookworm positive study participants > 2 years old  Both sex (female and male ) hookworm positive participants  Pregnant women  Patients undertake anthelminthic drugs during data collection time within the past 6 weeks)  Participants with medication with known interaction (e.g. for albendazole: cimetidine, praziquantel, and dexamethasone)  Patients who had a history of severe chronic disease (e.g.cancer, diabetes, chronic heart, liver or renal disease).  Participants having diarrhea or vomiting Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 73 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 10/01/2020 Ethical Committe of the School of Biomedical and Laboratory Science College of Medicine and Health Sciences University of Gondar
Ethics Committee Address
Street address City Postal code Country
Gondar Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure rate and egg reduction rates of single doses of albendazole were the primary outcomes of this study 14-21
Secondary Outcome MIC of albendazole killing effects for hookworm larva in culture media 48hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adet primary Hospital in Yilmana Dendssa woreda West Gojam Adet - Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Amhara Regional Health Bureau Bahir Dar Bahir Dar - Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Amhara Regional Health Bureau Bahir Dar Bahir Dar - Ethiopia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wolelaw Bazie wolleju982@gmail.com +251920350799 Adet
City Postal code Country Position/Affiliation
Adet - Ethiopia Adet primary Hospital in Yilmana Dendssa woreda
Role Name Email Phone Street address
Scientific Enquiries Adane Derso adanedm77@gmail.com +251930706000 Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Department of medical parasitology school of biomedical and laboratory sciences college of medicine and health sciences University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Tegegne Eshetu tegegneeshetu5@gmail.com +251921738483 Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Department of Medical Parasitology School of Biomedical and Laboratory Sciences College of Medicine and Health Sciences University of Gondar
Role Name Email Phone Street address
Public Enquiries Ayalew Jejaw ayalewjejaw@gmail.com +251910208492 Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Department of Medical Parasitology School of Biomedical and Laboratory Sciences College of Medicine and Health sciences University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data were coded using the specific identification number for the sake of data confidentiality. Study Protocol The IPD of this study will be shared after the completion of the study. All available information will available on the hand of the principal investigators and we all are willing to share the date when it is required. up to any legal bodies request the data of this work require the principal investigators will let to share the data accordingly.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 14/10/2020 edit In vivo and in vitro anti-hookworm effect of Single dose of Albendazole among outpatients at Adet primary Hospital, Northwest, Ethiopia In vivo and in vitro anti-hookworm effect of Single dose of Albendazole among outpatients at Adet primary Hospital, Northwest, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 14/10/2020 edit In vivo and in vitro anti-hookworm effect of Single dose of Albendazole among outpatients at Adet primary Hospital, Northwest, Ethiopia In vivo and in vitro anti-hookworm effect of Single dose of Albendazole among outpatients at Adet primary Hospital, Northwest, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 14/10/2020 It was incomplete Now it is filed according to the reviewer's comment. Amhara Regional Health Bureau, Bahir Dar, Bahir Dar, -, Ethiopia, Government Body,