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Tests treatment safety and results for Pneumonia, Community-Acquired
Official title Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)
ClinicalTrials.gov ID: NCT06804096
What this study is testing
What is Faropenem?
Faropenem is an investigational medicine, given as an once-daily, being studied as a potential treatment for pneumonia, community-acquired.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the efficacy and safety of faropenem in comparison to co-amoxiclav and clarithromycin in Bangladeshi adults diagnosed with community-acquired bacterial pneumonia (CABP). Eligible participants will be randomly assigned to one of two treatment arms.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female patients aged between 18 to 65 years.
- Have an acute illness (less than or equal to 7 days duration) with any of the following signs and symptoms consistent with a lower respiratory tract...
- Fever (body temperature \> 38.0 °C (100.4 °F) measured orally)
- Shortness of breath
- New onset or increased cough with or without sputum production.
You likely can't join if
- Patients with severe pneumonia (Clinical \& Radiological Assessment)
- Patients with suspicion of viral pneumonia (bilateral, patchy opacities, etc., in chest radiography.)
- Patients with suspicion of nosocomial pneumonia, aspiration pneumonia, etc.
- History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs.
- Intake of an antibiotic within the last 48 hours before study admission.
- History of hospitalization within the last 28 days.
See the full eligibility criteria
- Male or female patients aged between 18 to 65 years.
- Have an acute illness (less than or equal to 7 days duration) with any of the following signs and symptoms consistent with a lower respiratory tract infection (new or worsening):
- Fever (body temperature \> 38.0 °C (100.4 °F) measured orally)
- Shortness of breath
- New onset or increased cough with or without sputum production.
- Chest pain.
- Have radiographically documented bacterial pneumonia:
- Infiltrates in a unilateral, lobar distribution
- Diffuse opacities or white condensed area
- The alveoli fill with white inflammatory fluid
- Patients with severe pneumonia (Clinical \& Radiological Assessment)
- Patients with suspicion of viral pneumonia (bilateral, patchy opacities, etc., in chest radiography.)
- Patients with suspicion of nosocomial pneumonia, aspiration pneumonia, etc.
- History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs.
- Intake of an antibiotic within the last 48 hours before study admission.
- History of hospitalization within the last 28 days.
- Patients in pregnancy and lactational state.
- Patients with Renal impairment (screening eGFR \< 30mL/min).
- Significant hepatic impairment (Alanine aminotransferase \> three times the upper limit of normal).
- Serious diseases that affect the immune system, such as Acquired Immunodeficiency Syndrome (AIDS), cancer, etc.
- Patients who are taking steroid medications, at least 20 mg daily dose of prednisolone (or equivalent doses of other glucocorticoids).
- Patients who are accepting chemotherapy or anti-cancer therapy or plan to receive such treatment during the trial or six months prior to enrollment.
- Had epilepsy, stroke, or other central nervous system disorders or uncontrolled psychiatric history.
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Dhaka Division, Bangladesh
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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Dhaka Division, Bangladesh. 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.