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.: PACTR202111611256940 Date of Approval: 30/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessing the Potential of C-Reactive Protein Testing to Reduce Antibiotic Dispensation for Respiratory Tract Infections by Community Pharmacists in Nigeria: A Cluster Randomised Controlled Trial
Official scientific title Assessing the Potential of C-Reactive Protein Testing to Reduce Antibiotic Dispensation for Respiratory Tract Infections by Community Pharmacists in Nigeria: A Cluster Randomised Controlled Trial
Brief summary describing the background and objectives of the trial In Nigeria, bacteria responsible for different infections frequently resist the antibiotics used to eliminate them, making the treatment of infectious diseases difficult. Antibiotics overuse facilitates the spread of resistant bacteria. Overuse occurs in community pharmacies where community pharmacists dispense antibiotics to patients without prescriptions. This is particularly the case when patients present with symptoms of respiratory tract infections (RTI). This study aims to ascertain if providing community pharmacists in Awka (Nigeria) with C-reactive protein (CRP) test kits and training them on how to use the kits to assess antibiotic needs in patients with RTI symptoms will reduce their dispensation of antibiotics to such patients. A cluster randomised controlled trial will be conducted. Clusters will be community pharmacies in Awka.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CRP Trial
Disease(s) or condition(s) being studied Antibiotic use for respiratory tract infections
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/01/2022
Actual trial start date 21/01/2022
Anticipated date of last follow up 29/04/2022
Actual Last follow-up date 23/07/2022
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
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 Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual practice 30 days Community pharmacists in the control group will receive no intervention. They will manage patients with symptoms of RTI as they usually do. 10 Active-Treatment of Control Group
Experimental Group CRP test kits provision and training 30 days Community pharmacists in the intervention group will be provided with CRP test kits and trained on how to use them to ascertain when patients with symptoms of RTI require antibiotics. This training will draw on the guide provided by the manufacturer of the CRP test kits and the recommendations provided by the British National Institute for Clinical Excellence (NICE) on how to interpret the results of CRP testing. They will also be advised to continue purchasing and using CRP kits when they exhaust their kits. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included, a community pharmacy must be registered with the Pharmacists Council of Nigeria (PCN) and have at least one pharmacist, who is registered with PCN, on duty always. Prospective community pharmacies will be excluded if their managements do not consent to their participating or if their community pharmacists already use a diagnostic technique to inform antibiotic dispensation to patients with RTI symptoms. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 100 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 15/11/2021 Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Chukwuemeka Odumegwu Ojukwu University Teaching Hospital Awka 420110 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This is the rate at which community pharmacists dispense antibiotics to patients with symptoms of RTI. Outcome will be measured daily for 30 days before and after the intervention.
Secondary Outcome This is the rate at which community pharmacists incorporate the results of objective medical tests when making decisions regarding antibiotic dispensation to patients with symptoms of RTI. Outcome will be measured daily for 30 days before and after the intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Awka Awka Awka Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Royal Society of Tropical Medicine and Hygiene Northumberland House, 303-306 High Holborn London WC1V7JZ United Kingdom
National Institute for Health Research 39 Victoria Street London SW1H 0EU United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Augustine Onwunduba Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420110 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Obinna Ekwunife Department of Clinical Pharmacy and Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Awka 420110 Nigeria
Dr Chukwuanugo Ogbuagu Department of Medical Microbiology and Parasitology, Faculty of Medicine, Nnamdi Azikiwe University Awka 420110 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Augustine Onwunduba ae.onwunduba@unizik.edu.ng +2347061175220 Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420110 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Augustine Onwunduba ae.onwunduba@unizik.edu.ng +2347061175220 Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420110 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Augustine Onwunduba ae.onwunduba@unizik.edu.ng +2347061175220 Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 420110 Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the data collected from participating community pharmacies during the trial will be available for sharing, after they have been carefully deidentified. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available for 5 years from the date the study is published. Researchers who wish to access the data resulting from this study must send a request to the principal investigator through ae.onwunduba@unizik.edu.ng. The principal investigator will review and grant access to researchers whose requests are reasonable, after they have signed relevant data access agreements.
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