Respiratory Infections in ChildrenSTARNCT05294510
Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda
A study testing STAR Sick Child Job Aid in people with Respiratory Infections in Children, run by University of North Carolina, Chapel Hill at 1 site in Uganda.
Trial summary
This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern… Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Respiratory Infections in Children
- What is being tested?
- STAR Sick Child Job Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 1 siteUganda
- Study dates
- 2 Nov 2021to 30 May 2022
- 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 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2 months-5 years
- Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature > 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate > 30) OR cough
Who cannot join
- Age > 5 years or < 2 months at time of presentation
- Guardian not present to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers
This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.
The purpose of this study is to assess the impact of the algorithm on antibiotic use.
- Conditions
- Respiratory Infections in Children
- Being tested
- STAR Sick Child Job Aid
- Keywords
- Community health workers, C-reactive protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR Sick Child Job AidOther
The STAR Sick Child Job Aid is a modified ICCM protocol that includes the addition of a point-of-care C-reactive protein (CRP) test to inform antibiotic treatment decisions for children presenting with febrile acute respiratory illness who do not have any danger signs. If CRP ≥ 40 mg/L, the village health worker (VHW) will dispense amoxicillin per local guidelines. If CRP < 40 mg/L, the VHW will advise symptomatic care alone including acetaminophen for fever and additional fluids to maintain hydration.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Children who present to a village health worker during a control period are evaluated and managed using the current standard of care per Uganda National Guidelines for Integrated Community Case Management (ICCM). Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design. |
| Intervention | Experimental | Children who present to a village health worker during an intervention period are evaluated and managed using a modified ICCM algorithm that includes point-of-care C-reactive protein testing. Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design. Receives: Other: STAR Sick Child Job Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescriptions at baseline visit
Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition.
Measured: Baseline visit
Secondary outcomes (8)
Clinical Failure (Composite Outcome)
Proportion of children with one or more of the following outcomes in the control as compared to the intervention condition: persistence of fever at Day 7, development of danger signs as defined by local Integrated Community Care Management guidelines at any time during the seven-day follow-up period, need for hospitalization at any time during follow-up period, or death at any time during follow-up period.
Measured: Between baseline visit and Day 7 follow-up assessment
Unexpected visits
Proportion of children brought to the village health worker during the seven-day follow-up period for persistent or worsening symptoms by their caregiver in the control as compared to the intervention condition.
Measured: Between baseline visit and Day 7 follow-up assessment
Perceived improvement per caregiver
Proportion of caregivers who perceive that their child has clinically improved at the Day 7 follow-up assessment in the control as compared to the intervention condition.
Measured: Day 7
Persistent fever
Proportion of children who have persistence of subjective or documented fever at the Day 7 follow-up assessment in the control as compared to the intervention condition.
Measured: Day 7
Development of danger signs
Proportion of children who develop danger signs (as defined by local Integrated Community Care Management guidelines) during the seven-day follow-up period in the control as compared to intervention conditions.
Measured: Between Day 1 and Day 7
Hospitalization
Proportion of children who require inpatient admission to a health facility during the seven-day follow-up period in the control as compared to intervention periods.
Measured: Between Day 1 and Day 7
Death
Proportion of children who die during the seven-day follow-up period in the control as compared to intervention periods.
Measured: Between Day 1 and Day 7
Antibiotic prescriptions during study follow-up
Proportion of children prescribed antibiotics by any provider either at the baseline visit or during the seven-day follow-up period in the control as compared to the intervention condition.
Measured: Between baseline visit and Day 7 follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start2 Nov 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge, cluster randomized trial with 5 clusters or treatment sequences of 3 villages each. Villages are first stratified by altitude, proximity to the local health center, and size (based on approximate number of children seen by the village health workers per year) into one of three strata: (1) low altitude, proximal, large, (2) low altitude, mid-distance, medium, (3) high altitude, distal, small. One village is then randomly selected from each strata for each of the 5 clusters. All clusters start in the control condition and one cluster crosses over from control to intervention each month.
- Masking
- None (open label)
- Enrolment
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Emily J Ciccone, MD, MHS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294510
- Sponsor's protocol ID
- 18-2803
- Other IDs
- 15206
- Acronym
- STAR
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that underlie the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Ciccone EJ, Hu D, Preisser JS, Cassidy CA, Kabugho L, Emmanuel B, Kibaba G, Mwebembezi F, Juliano JJ, Mulogo EM, Boyce RM. Point-of-care C-reactive protein measurement by community health workers safely reduces antimicrobial use among children with respiratory illness in rural Uganda: A stepped wedge cluster randomized trial. PLoS Med. 2024 Aug 19;21(8):e1004416. doi: 10.1371/journal.pmed.1004416. eCollection 2024 Aug.
PubMed 39159269
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers
- ClinicalTrials.gov ID
- NCT05294510
- Acronym / sponsor ID
- STAR / 18-2803
- Conditions
- Respiratory Infections in Children
- Keywords
- Community health workers, C-reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 24 Mar 2022 (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 stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.
The purpose of this study is to assess the impact of the algorithm on antibiotic use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge, cluster randomized trial with 5 clusters or treatment sequences of 3 villages each. Villages are first stratified by altitude, proximity to the local health center, and size (based on approximate number of children seen by the village health workers per year) into one of three strata: (1) low altitude, proximal, large, (2) low altitude, mid-distance, medium, (3) high altitude, distal, small. One village is then randomly selected from each strata for each of the 5 clusters. All clusters start in the control condition and one cluster crosses over from control to intervention each month.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Children who present to a village health worker during a control period are evaluated and managed using the current standard of care per Uganda National Guidelines for Integrated Community Case Management (ICCM). Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design. |
| Intervention | Experimental | Other: STAR Sick Child Job AidChildren who present to a village health worker during an intervention period are evaluated and managed using a modified ICCM algorithm that includes point-of-care C-reactive protein testing. Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design. |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 2 months-5 years
- Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature > 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate > 30) OR cough
Key exclusion criteria (2 listed)
- Age > 5 years or < 2 months at time of presentation
- Guardian not present to provide consent
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 |
|---|---|---|
| STAR Sick Child Job AidThe STAR Sick Child Job Aid is a modified ICCM protocol that includes the addition of a point-of-care C-reactive protein (CRP) test to inform antibiotic treatment decisions for children presenting with febrile acute respiratory illness who do not have any danger signs. If CRP ≥ 40 mg/L, the village health worker (VHW) will dispense amoxicillin per local guidelines. If CRP < 40 mg/L, the VHW will advise symptomatic care alone including acetaminophen for fever and additional fluids to maintain hydration. | Other | Intervention |
Primary outcome
Antibiotic prescriptions at baseline visit
Time frame: Baseline visit
Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition.
8 secondary outcomes
Clinical Failure (Composite Outcome)
Time frame: Between baseline visit and Day 7 follow-up assessment
Unexpected visits
Time frame: Between baseline visit and Day 7 follow-up assessment
Perceived improvement per caregiver
Time frame: Day 7
Persistent fever
Time frame: Day 7
Development of danger signs
Time frame: Between Day 1 and Day 7
Hospitalization
Time frame: Between Day 1 and Day 7
Death
Time frame: Between Day 1 and Day 7
Antibiotic prescriptions during study follow-up
Time frame: Between baseline visit and Day 7 follow-up assessment
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 4 Aug 2022.
- Derived from this study: PubMed 39159269Ciccone EJ, Hu D, Preisser JS, Cassidy CA, Kabugho L, Emmanuel B, Kibaba G, Mwebembezi F, Juliano JJ, Mulogo EM, Boyce RM. Point-of-care C-reactive protein measurement by community health workers safely reduces antimicrobial use among children with respiratory illness in rural Uganda: A stepped wedge cluster randomized trial. PLoS Med. 2024 Aug 19;21(8):e1004416. doi: 10.1371/journal.pmed.1004416. eCollection 2024 Aug.
- Individual participant dataSharing planned: Yes. Deidentified individual data that underlie the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Emily J Ciccone, MD, MHS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Sick Child Job Aid in people with Respiratory Infections in Children, run by University of North Carolina, Chapel Hill 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 2 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: finished, as of the sponsor's last update on 4 Aug 2022. 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?
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?
Antibiotic prescriptions at baseline visit (time frame: Baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294510, which also lists 1 linked publication.
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 Aug 2022.