PneumoniaNCT06830915
Evaluation of Current Practice of Antimicrobial Use and Clinical Outcome in the Management of Pneumonia Among Pediatric Patients Admitted to Jimma Medical Center, Southwest Ethiopia: A Prospective Observational Study
An observational study of Pneumonia and Bacterial, run by Bule Hora University at 1 site in Ethiopia.
Trial summary
A prospective observational study design was conducted on children admitted to the pediatric wards of Jimma Medical Center. The study was conducted from February 03, 2022, to June 03, 2022, and patients aged < 18 years and diagnosed with pneumonia were included. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- What is being tested?
- Observation only
- How many people
- 161 participants
- Where
- 1 siteEthiopia
- Study dates
- 3 Feb 2022to 3 Jun 2022
- Phase
- Observational
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All pediatric patients admitted to the pediatric ward of the Jimma Medical Center with a diagnosis of pneumonia during the study period were screened for eligibility criteria.
Who may be able to join
- Patients aged less than or equal to 18 years admitted to the pediatric wards of Jimma Medical Center with a suspected or proven pneumonia diagnosis by physician decision on duty during the study period and Patients whose parents gave assent were included in the study.
Who cannot join
- Patients who died before they started antimicrobial, transferred to other facilities and patient lost follow-up were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective observational study design was conducted on children admitted to the pediatric wards of Jimma Medical Center. The study was conducted from February 03, 2022, to June 03, 2022, and patients aged < 18 years and diagnosed with pneumonia were included. A chart review supplemented by a self-administered questionnaire was used to collect data. Descriptive statistics and binary logistic regressions were performed for data analyses.
Read the detailed description
2.2 Study Design A hospital-based prospective observational study was conducted in children with pneumonia admitted to the pediatric ward of Jimma Medical Center.
2.3 Participant Eligibility and Inclusion All pediatric patients admitted to the pediatric ward of the Jimma Medical Center with a diagnosis of pneumonia during the study period were screened for eligibility criteria. Patients aged less than or equal to 18 years admitted to the pediatric wards of Jimma Medical Center with a suspected or proven pneumonia diagnosis by physician decision on duty during the study period and Patients whose parents gave assent were included in the study. Patients who died before they started antimicrobial, transferred to other facilities and patient lost follow-up were excluded.
2.4 Sample Size and Sampling Technique No sampling technique was applied; instead, all pediatric patients diagnosed with pneumonia that fulfilled illegibility criteria during the study period were recruited in the study. Accordingly, 146 patients were followed and completed data collected.
2.5 Data Collection Instrument and Quality Assurance The data collections instrument (data abstraction format and self-administered questionnaire) was developed by reviewing the literature on antimicrobial use, antimicrobial resistance, and antimicrobial stewardship program guidelines. Training was given for data collectors on the data collection procedure and research objectives. The principal investigator was regularly checking the consistency and completeness of the data and random checks were also being performed.
2.6 Data Processing and Analysis Data was compiled, cleared, coded, and verified for completeness and accuracy before being included in Epi Data Manager version 4.6.2. Double-entry verification was performed and the data was analyzed using statistical software, SPSS version 25.0. Descriptive statistics (mean, frequency, and cross tabulation) were used to describe practice of antimicrobial use. The bivariate logistic regression was performed for clinical outcome and variables with p-values less than 0.25 with outcomes (poor outcome or good outcome) were taken into account for further analysis. Then, the independent predictors were identified by multivariate logistic regression analysis. All statistical tests were detailed; a P value of less than or equal to 0.05 was considered statistically significant.
- Being tested
- Observation only
- Keywords
- Antimicrobial, use, Current, practice, Jimma, Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation onlyOther
No intervention made
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotics use pattern
Current practice of antimicrobial agents
Measured: February 03,2022 to June 03,2022
Clinical outcome
Clinical treatment outcome(As poor vs good)
Measured: February 03,2022 to June 03,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start3 Feb 2022
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bule Hora University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University
- Responsible party
- Principal investigator, Abduba Wariyo Guyo, Bule Hora University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830915
- Sponsor's protocol ID
- Ref. No. JUIRB016/21
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Current Practice of Antimicrobial Use and Clinical Outcome in the Management of Pneumonia Among Pediatric Patients Admitted to Jimma Medical Center, Southwest Ethiopia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06830915
- Acronym / sponsor ID
- Ref. No. JUIRB016/21
- Keywords
- Antimicrobial, use, Current, practice, Jimma, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Bule Hora UniversityUniversity, hospital or other
- Collaborators
- Jimma University
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 17 Feb 2025 (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.
A prospective observational study design was conducted on children admitted to the pediatric wards of Jimma Medical Center. The study was conducted from February 03, 2022, to June 03, 2022, and patients aged < 18 years and diagnosed with pneumonia were included. A chart review supplemented by a self-administered questionnaire was used to collect data. Descriptive statistics and binary logistic regressions were performed for data analyses.
Detailed description
2.2 Study Design A hospital-based prospective observational study was conducted in children with pneumonia admitted to the pediatric ward of Jimma Medical Center.
2.3 Participant Eligibility and Inclusion All pediatric patients admitted to the pediatric ward of the Jimma Medical Center with a diagnosis of pneumonia during the study period were screened for eligibility criteria. Patients aged less than or equal to 18 years admitted to the pediatric wards of Jimma Medical Center with a suspected or proven pneumonia diagnosis by physician decision on duty during the study period and Patients whose parents gave assent were included in the study. Patients who died before they started antimicrobial, transferred to other facilities and patient lost follow-up were excluded.
2.4 Sample Size and Sampling Technique No sampling technique was applied; instead, all pediatric patients diagnosed with pneumonia that fulfilled illegibility criteria during the study period were recruited in the study. Accordingly, 146 patients were followed and completed data collected.
2.5 Data Collection Instrument and Quality Assurance The data collections instrument (data abstraction format and self-administered questionnaire) was developed by reviewing the literature on antimicrobial use, antimicrobial resistance, and antimicrobial stewardship program guidelines. Training was given for data collectors on the data collection procedure and research objectives. The principal investigator was regularly checking the consistency and completeness of the data and random checks were also being performed.
2.6 Data Processing and Analysis Data was compiled, cleared, coded, and verified for completeness and accuracy before being included in Epi Data Manager version 4.6.2. Double-entry verification was performed and the data was analyzed using statistical software, SPSS version 25.0. Descriptive statistics (mean, frequency, and cross tabulation) were used to describe practice of antimicrobial use. The bivariate logistic regression was performed for clinical outcome and variables with p-values less than 0.25 with outcomes (poor outcome or good outcome) were taken into account for further analysis. Then, the independent predictors were identified by multivariate logistic regression analysis. All statistical tests were detailed; a P value of less than or equal to 0.05 was considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All pediatric patients admitted to the pediatric ward of the Jimma Medical Center with a diagnosis of pneumonia during the study period were screened for eligibility criteria.
Key inclusion criteria (1 listed)
- Patients aged less than or equal to 18 years admitted to the pediatric wards of Jimma Medical Center with a suspected or proven pneumonia diagnosis by physician decision on duty during the study period and Patients whose parents gave assent were included in the study.
Key exclusion criteria (1 listed)
- Patients who died before they started antimicrobial, transferred to other facilities and patient lost follow-up were excluded.
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 |
|---|---|---|
| Observation onlyNo intervention made | Other | – |
Primary outcome
Antibiotics use pattern
Time frame: February 03,2022 to June 03,2022
Current practice of antimicrobial agents
Clinical outcome
Time frame: February 03,2022 to June 03,2022
Clinical treatment outcome(As poor vs good)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Bacterial, run by Bule Hora University at 1 site in Ethiopia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Feb 2025. 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 Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotics use pattern (time frame: February 03,2022 to June 03,2022). The study lists 2 primary outcomes in all. 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 19 Feb 2025.