ATC/DDDNCT04782011
Using the ATC/DDD to Monitor Antibiotic Use at Lower Primary Care Facilities in Southwestern Uganda
A study testing ATC/DDD in people with ATC/DDD and Antibiotic Utilization, run by Makerere University at 1 site in Uganda.
Trial summary
This is a non blinded two arm cluster randomized control trial, aimed at assessing the feasibility of using the Anatomical Therapeutic Chemical Classification/define Daily Doses system tool to monitor antibiotic use at lower primary levels of care in Uganda. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- ATC/DDD, Antibiotic Utilization
- What is being tested?
- ATC/DDD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,406 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health facility: The facility will be government owned that receives antibiotics from National Medical Stores using the current schedule and has no ongoing antibiotic use related intervention study.
- Prescribers: Male and female prescribers at primary care facilities in the selected districts of Mbarara, Bushenyi and Kasese will be recruited. Prescribers with an experience of at least 3 months in antibiotic prescribing and inventory at these facilities will be included in the study. These shall be identified through the in-charges of the respective facilities.
- Patients: New male and female adult patients (18 years and above) receiving antibiotic medication will be enrolled.
- Antibiotic utilization records: Antibiotic prescriptions and administration charts for new patients at selected health facilities.
Who cannot join
- Patients: Those who are too sick to cooperate
- Prescriptions: Ineligible prescriptions and the prescriber cannot be reached for clarifications.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Hanifah Nantongo
Mbarara
Hanifah Nantongo, Msc., +256773413926, hanyfah24@gmail.com
Jackson Mukonzo, PhD, +256772 593168, mukojack@yahoo.co.uk
About this study
Official title: Feasibility of Using the Chemical Classification System/Defined Daily Doses Tool to Monitor Antibiotic Use at Primary Healthcare Facilities in Southwestern Uganda
This is a non blinded two arm cluster randomized control trial, aimed at assessing the feasibility of using the Anatomical Therapeutic Chemical Classification/define Daily Doses system tool to monitor antibiotic use at lower primary levels of care in Uganda.
Read the detailed description
The study will evaluate the feasibility of using the ATC/DDD in three districts of Southwestern Uganda. The unit of intervention will be a health facility. Eighteen (18) randomly selected government owned health facilities at levels II, III and IV will be split evenly between the intervention and non intervention arms. Antibiotic prescriptions of new adult (in-patients and ambulatory) patients with antibiotic utilization records from the selected facilities will be enrolled in the study. The intervention is the introduction of the ATC/DDD plus the training on its importance and use by healthcare providers. The facilities selected will be far apart from each other to avoid contamination.
Intervention arm: The ATC/DDD tool shall be piloted in all selected facilities of the 3 randomly selected districts of Mbarara, Bushenyi and Kasese. The prescribers at these facilities will be trained about the importance and usability of the ATC/DDD tool. A pre and post assessment of the prescribers understanding of the tool's usability will be done prior to piloting the tool. This will guide the focus of the training and any other necessary support after the training. The trained prescribers will use the latest tool version to evaluate drug utilization of antibiotics (anti-infectives for systemic use) used at their respective facility levels for a period of 6 months. Prescriptions and drug administration reviews will be done in three phases and for 5 days following the National Medical Stores delivery schedule for medicines, that is, shortly after delivery of drugs (phase 1), midway (phase 2) and towards the end of the delivery period (phase 3). The evaluation will involve computation of antibiotic utilization parameters using the latest version of the ATC/DDD by both the trained healthcare providers and an independent research team. Findings will be compared for both groups to ensure implementation infidelity. .
Patients and antibiotic utilization records:
- For inpatients: On the day of patient recruitment, health workers will routinely conduct baseline assessment of the consented patients to obtain data on demographics, clinical conditions and medications. Daily reviews of patients shall be conducted as routinely done by the clinicians until discharge, referral, death or loss to follow-up. A data extraction template will then be used to capture both baseline and daily follow-up patient information . Medication data will be obtained from the patient's hospital file (clinical notes, treatment sheets and drug administration charts), dispensing records of ward units, pill count validation of a patient's oral medication (capsules, tablets,) and of unused injectable medicine vials or ampoules in the possession of the patient or the caregiver. This will be done on a daily basis.
- For ambulatory patients: Only prescription data will be obtained from Out-patient Department (OPD) registers, dispensing logs and/or patients' charts using a data extraction template.
Non-intervention arm: These will continue with the standard practice. However, the research team will collect data during the respective phases highlighted in the intervention arm for computation using the latest version of the ATC/DDD tool and comparison.
- Conditions
- ATC/DDD, Antibiotic Utilization
- Being tested
- ATC/DDD
- Keywords
- ATC/DDD, Antibiotic utilization, Lower primary care facilities, Southwestern Uganda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATC/DDDBehavioural
The intervention is the introduction of the ATC/DDD including the training on its importance and usage in monitoring antibiotic use at a given primary care facility.
| Study group | Role | What they receive |
|---|---|---|
| ATC/DDD arm | Experimental | The intervention is the introduction of the ATC/DDD including the training of healthcare workers on its importance and usage in monitoring antibiotic use. The unit of intervention will be a health facility. Antibiotic prescriptions and antibiotic utilization records for adult patients (in-patients and ambulatory) from the selected facilities will be enrolled in the study. Receives: Behavioral: ATC/DDD |
| Control arm | No intervention | The health care workers will continue with standard practice. However, the research team will collect data on antibiotic prescriptions and antibiotic utilization for adult patients (in-patients and ambulatory) from the selected facilities. The data will be compared with that of the intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trends in antibiotic utilization for both the intervention and non intervention arms
Computation of antibiotic utilization parameters across the different facility levels will be done using the latest version of the ATC/DDD tool. Antibiotic use by clinical condition data will be analyzed using working diagnoses that will be classified into diagnostic groups using the latest version of the International Classification of Diseases, Clinical Modification (ICD-10-CM) diagnosis codes as a guide. Findings of both arms will be compared.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATC/DDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The number of health facilities will be split evenly between the intervention and non intervention arms. These will be randomly selected in the districts of Mbarara, Bushenyi and Kasese.
- Masking
- None (open label)
- Enrolment
- 1,406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA), Mbarara University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Jackson Mukonzo, PhD, Study director, Makerere UniversityVincent Batwala, PhD, Study director, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782011
- Sponsor's protocol ID
- SBS-HDREC-564
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not intend to share the data
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using the Chemical Classification System/Defined Daily Doses Tool to Monitor Antibiotic Use at Primary Healthcare Facilities in Southwestern Uganda
- ClinicalTrials.gov ID
- NCT04782011
- Acronym / sponsor ID
- SBS-HDREC-564
- Conditions
- ATC/DDD, Antibiotic Utilization
- Keywords
- ATC/DDD, Antibiotic utilization, Lower primary care facilities, Southwestern Uganda
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,406 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA), Mbarara University of Science and Technology
- Study start
- Mar 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non blinded two arm cluster randomized control trial, aimed at assessing the feasibility of using the Anatomical Therapeutic Chemical Classification/define Daily Doses system tool to monitor antibiotic use at lower primary levels of care in Uganda.
Detailed description
The study will evaluate the feasibility of using the ATC/DDD in three districts of Southwestern Uganda. The unit of intervention will be a health facility. Eighteen (18) randomly selected government owned health facilities at levels II, III and IV will be split evenly between the intervention and non intervention arms. Antibiotic prescriptions of new adult (in-patients and ambulatory) patients with antibiotic utilization records from the selected facilities will be enrolled in the study. The intervention is the introduction of the ATC/DDD plus the training on its importance and use by healthcare providers. The facilities selected will be far apart from each other to avoid contamination.
Intervention arm: The ATC/DDD tool shall be piloted in all selected facilities of the 3 randomly selected districts of Mbarara, Bushenyi and Kasese. The prescribers at these facilities will be trained about the importance and usability of the ATC/DDD tool. A pre and post assessment of the prescribers understanding of the tool's usability will be done prior to piloting the tool. This will guide the focus of the training and any other necessary support after the training. The trained prescribers will use the latest tool version to evaluate drug utilization of antibiotics (anti-infectives for systemic use) used at their respective facility levels for a period of 6 months. Prescriptions and drug administration reviews will be done in three phases and for 5 days following the National Medical Stores delivery schedule for medicines, that is, shortly after delivery of drugs (phase 1), midway (phase 2) and towards the end of the delivery period (phase 3). The evaluation will involve computation of antibiotic utilization parameters using the latest version of the ATC/DDD by both the trained healthcare providers and an independent research team. Findings will be compared for both groups to ensure implementation infidelity. .
Patients and antibiotic utilization records:
- For inpatients: On the day of patient recruitment, health workers will routinely conduct baseline assessment of the consented patients to obtain data on demographics, clinical conditions and medications. Daily reviews of patients shall be conducted as routinely done by the clinicians until discharge, referral, death or loss to follow-up. A data extraction template will then be used to capture both baseline and daily follow-up patient information . Medication data will be obtained from the patient's hospital file (clinical notes, treatment sheets and drug administration charts), dispensing records of ward units, pill count validation of a patient's oral medication (capsules, tablets,) and of unused injectable medicine vials or ampoules in the possession of the patient or the caregiver. This will be done on a daily basis.
- For ambulatory patients: Only prescription data will be obtained from Out-patient Department (OPD) registers, dispensing logs and/or patients' charts using a data extraction template.
Non-intervention arm: These will continue with the standard practice. However, the research team will collect data during the respective phases highlighted in the intervention arm for computation using the latest version of the ATC/DDD tool and comparison.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The number of health facilities will be split evenly between the intervention and non intervention arms. These will be randomly selected in the districts of Mbarara, Bushenyi and Kasese.
| Arm | Type | Receives |
|---|---|---|
| ATC/DDD arm | Experimental | Behavioral: ATC/DDDThe intervention is the introduction of the ATC/DDD including the training of healthcare workers on its importance and usage in monitoring antibiotic use. The unit of intervention will be a health facility. Antibiotic prescriptions and antibiotic utilization records for adult patients (in-patients and ambulatory) from the selected facilities will be enrolled in the study. |
| Control arm | No intervention | –The health care workers will continue with standard practice. However, the research team will collect data on antibiotic prescriptions and antibiotic utilization for adult patients (in-patients and ambulatory) from the selected facilities. The data will be compared with that of the intervention arm. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Health facility: The facility will be government owned that receives antibiotics from National Medical Stores using the current schedule and has no ongoing antibiotic use related intervention study.
- Prescribers: Male and female prescribers at primary care facilities in the selected districts of Mbarara, Bushenyi and Kasese will be recruited. Prescribers with an experience of at least 3 months in antibiotic prescribing and inventory at these facilities will be included in the study. These shall be identified through the in-charges of the respective facilities.
- Patients: New male and female adult patients (18 years and above) receiving antibiotic medication will be enrolled.
- Antibiotic utilization records: Antibiotic prescriptions and administration charts for new patients at selected health facilities.
Key exclusion criteria (2 listed)
- Patients: Those who are too sick to cooperate
- Prescriptions: Ineligible prescriptions and the prescriber cannot be reached for clarifications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATC/DDDThe intervention is the introduction of the ATC/DDD including the training on its importance and usage in monitoring antibiotic use at a given primary care facility. | Behavioural | ATC/DDD arm |
Primary outcome
Trends in antibiotic utilization for both the intervention and non intervention arms
Time frame: 3 months
Computation of antibiotic utilization parameters across the different facility levels will be done using the latest version of the ATC/DDD tool. Antibiotic use by clinical condition data will be analyzed using working diagnoses that will be classified into diagnostic groups using the latest version of the International Classification of Diseases, Clinical Modification (ICD-10-CM) diagnosis codes as a guide. Findings of both arms will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No. I do not intend to share the data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackson Mukonzo, PhD study director
Makerere University
Vincent Batwala, PhD study director
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATC/DDD in people with ATC/DDD and Antibiotic Utilization, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanifah Nantongo, MSc (+256773413926 ext. +256773413926, hanyfah24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trends in antibiotic utilization for both the intervention and non intervention arms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.