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.: PACTR202407793260730 Date of Registration: 23/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Breakthrough in Ascaris lumbricoid Treatment: Single-Dose Albendazole Proves Effective in Ethiopian School children
Official scientific title Breakthrough in Ascaris lumbricoid Treatment: Single-Dose Albendazole Proves Effective in Ethiopian School children
Brief summary describing the background and objectives of the trial Ascaris lumbercoides remains a significant health challenge mainly among impoverished school children. The WHO advocates the mass drug administration with single dose of albendazole (ALB) for prevention of this parasite .Yet extensive use of ALB might leads to selective drug resistance, hindering efforts to achieve disease elimination goals and needs continuous monitoring of its efficacy. Thus this study aimed to evaluate therapeutic efficacy of ALB against ascariasis and re-infection rates among school children at Northwest Ethiopia.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2023
Actual trial start date 01/06/2023
Anticipated date of last follow up 21/06/2023
Actual Last follow-up date 01/09/2023
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL Yet not 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
Single Group 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 Albendazole drug Single does (400mg) of Albendazole regimens for 14-21 days after treatments for efficacy determination and after three months for re-infection assessment All Ascaris lumbericoid microscopy postive school childern who met inclusion criteria were recived single dose (400mg) of Albendazole orally once .This drug was obtained from local market and deworming programs . Then the drug efficacy were evaluated in terms of cure and egg reduction rate after 14-21 days of Albendoze treatments . Moreover, the magnitude of re-infection was assessed after the three month of Albendazole treatment among this participants who were cured at 14-21 days. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All school children whose ages ranged from 7-14 years old attending and who had microscopically confirmed A. lumbricoid mono-infection without history of anti-helminthic drugs in take within the last 6 months before study period and able to to provide required stool samples at the baseline, after 2- 3 weeks and 3 months of baseline albendazole treatment were included in the study School-age children unable to bring parents/legal guardian to the school, who have a history of known major systemic or chronic illnesses, malnutrition, and GIT diseases, who take anti-inflammatory drugs/ antibiotics during the study period based on vital signs and prior clinical history, who have been vomiting within 4 hours after drug administration, experienced diarrhea , severe allergic reaction to albendazole, Infected with other than intestinal parasite than A.lumbricoide were excluded from the study Child: 6 Year-12 Year 6 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 15/05/2023 Ethical review committe of school of biomedical and laboratory science university of Gondar college
Ethics Committee Address
Street address City Postal code Country
Chechela street ,Gondar,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 or at 14-21 days At 14-21 days and after three months of albendzole treatment
Secondary Outcome Egg reduction rate or ERR. 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. At the 14-21 days of albendazole treatment
Secondary Outcome Magnitude of reinfection . The proportion childern who was cured at 14-21 days of treatment divided by the number of re-infected after the three months of albednazole treatments After the three months of Albendazole treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chauhit primary school Dambyia district ,central Gondar Chauhit Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Thesis research Grant Northwest Ethiopia Gondar 0196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Mesgenaw Tefesa Northwest Ethiopia Gondar Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
Hana Mesgenaw Central Gondar, Northwest Ethiopia Gondar Ethiopia
Mebratu Tamir Central Gondar,Northwest Ethiopia Gondar Ethiopia
Tegegne Eshetu Central Gondar,Northwest Ethiopia Gondar Ethiopia
Ababaw Setgen Central Gondar,Northwest Ethiopia Gondar Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hana Mesgenaw hanamesganaw365@gmail.com +251918549103 central Gondar,Northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar Ethiopia Laboratory techinologist at Gondar city
Role Name Email Phone Street address
Scientific Enquiries Mebratu Tamir mebratut3@gmail.com +251946250209 central Gondar,Northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia Lectuer at university of Gondar
Role Name Email Phone Street address
Public Enquiries Tegegne Eshetu tegegneeshetu5@gmail.com +251918007997 central Gondar,Northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia Lectuer at University of Gondar
Role Name Email Phone Street address
Public Enquiries Ababaw Setegn abebawsetegn@gmail.com +251945807430 Central Gondar,Northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia Lectuer at 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 corresponding investigator (Mebratu Tamir) and we are willing to share it accordingly if it is needed Informed Consent Form It is available for a certain period of time on the hand of corresponding and principle authors f 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
No yet published Yes 16/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/07/2024 Result - 16/07/2024 Result - 16/07/2024 Result - 16/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information