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New treatment option for Lower Resp Tract Infection
Official title TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
ClinicalTrials.gov ID: NCT06331364
What this study is testing
- What it's testing
- This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka. The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Admitted within prior 48 hours
- Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:
- New cough or sputum production
- Chest pain
- Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
You likely can't join if
- Hospitalized recently (within last 28 days)
- If they have been enrolled into this clinical trial previously
- Surgery in the past 7 days
- If they are unable or unwilling to complete the follow-up encounter
- If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
- If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:
See the full eligibility criteria
- Admitted within prior 48 hours
- Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:
- New cough or sputum production
- Chest pain
- Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
- Abnormal lung examination
- Have evidence of acute infection, as indicated by at least one of the following:
- Self-reported fever or chills
- Documented fever ≥38 ̊ C (100.4 ̊ F)
- Documented hypothermia \<35.5 ̊ C (95.9 ̊ F)
- Leukocytosis (white blood cell count \>10,000/mm3)
- Leukopenia (white blood cell count \<3000/mm3)
- New altered mental status
- Ability and willingness of patient, parent or legally authorized representative (LAR) to give informed consent
- Ability of children 14-17 years of age to provide assent
- Ability to complete follow-up encounter at 30 days in person or by telephone
- Hospitalized recently (within last 28 days)
- If they have been enrolled into this clinical trial previously
- Surgery in the past 7 days
- If they are unable or unwilling to complete the follow-up encounter
- If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
- If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:
- Vasopressor therapy
- Cystic fibrosis
- Known severe immunosuppression (i. Cancer or another condition with neutropenia (absolute neutrophil count \<1000/ microL; ii. Solid- organ or hematopoietic stem-cell transplant within the previous 90 days; iii. Active...
- Have an accompanying non-respiratory infection
- Have evidence of a lung abscess or empyema
- Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation
The study team makes the final eligibility decision.
Where it's taking place
- Balapitiya, Sri Lanka
- Karapitiya, Sri Lanka
- Matara, Sri Lanka
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Balapitiya, Sri Lanka; Karapitiya, Sri Lanka; Matara, Sri Lanka. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.