Once-daily oral gatifloxacin vs three-times-daily co-amoxiclav in the treatment of patients with community-acquired pneumonia.
H Lode, P Magyar, J F Muir...
https://pubmed.ncbi.nlm.nih.gov/15191378Actively Recruiting
Phase 4
Age: 18Years - 65Years
All Genders
ID06804096
Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial
Led by Dr. Md. Alimur Reza · Updated on 2025-07-11
160
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of faropenem compared to co-amoxiclav plus clarithromycin in adults from Bangladesh diagnosed with community-acquired bacterial pneumonia (CABP). This randomized controlled trial aims to provide important information about faropenem's potential role in treating CABP, a condition with significant health impact and limited treatment options in the region. Participants will be randomly assigned to one of two groups. One group will receive faropenem tablets at a dose of 200 mg three times daily for seven days. The other group will receive co-amoxiclav 625 mg three times daily combined with clarithromycin 500 mg twice daily for seven days. Both groups will receive standard care alongside these treatments. Follow-up assessments will occur over four weeks to monitor progress. During the study, participants will undergo evaluations including monitoring clinical cure rates and adverse events within 10 to 14 days, early clinical response at 3 to 4 days, and tracking hospitalizations and intensive care needs up to 28 days. Researchers will also observe mortality rates and the frequency of serious side effects. These assessments help determine the treatments' impact and safety during and after therapy.
CONDITIONS
Brief Title
Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged between 18 to 65 years
- Acute illness lasting 7 days or less with fever, shortness of breath, new or increased cough, or chest pain
- Radiographically confirmed bacterial pneumonia showing specific lung infiltrates or opacities
You will not qualify if you...
- Severe pneumonia by clinical or radiological assessment
- Suspected viral pneumonia or hospital-acquired pneumonia
- Allergy or intolerance to study drugs
- Antibiotic use within 48 hours before admission
- Hospitalization within the last 28 days
- Pregnancy or breastfeeding
- Kidney impairment with eGFR less than 30 mL/min
- Significant liver impairment with elevated liver enzymes
- Serious immune system diseases like AIDS or cancer
- Use of high-dose steroids or recent chemotherapy
- History of epilepsy, stroke, CNS disorders, or uncontrolled psychiatric conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 to 14 days
Participants receive assigned antibiotic treatment for community-acquired bacterial pneumonia.
1 baseline visit and 1 follow-up visit within 10 to 14 days
Follow-up
Duration - up to 28 days
Participants are monitored for safety, adverse events, and clinical outcomes after treatment completion.
Approximately 1 to 2 visits for safety and outcome assessments
Trial Site Locations
Total: 2 locations
1
Popular Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh, 1205
Actively Recruiting
2
Shaheed Suhrawardy Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh, 1205
Actively Recruiting
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Research Team
P
Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Igor Rudan, Cynthia Boschi-Pinto, Zrinka Biloglav...
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David M Morens, Jeffery K Taubenberger, Anthony S Fauci
https://pubmed.ncbi.nlm.nih.gov/18710327Diagnostic tests for agents of community-acquired pneumonia.
John G Bartlett
https://pubmed.ncbi.nlm.nih.gov/21460288Risk factors for community-acquired pneumonia in adults in Europe: a literature review.
Antoni Torres, Willy E Peetermans, Giovanni Viegi...
https://pubmed.ncbi.nlm.nih.gov/24130229The bacterial aetiology of adult community-acquired pneumonia in Asia: a systematic review.
Leon Peto, Behzad Nadjm, Peter Horby...
https://pubmed.ncbi.nlm.nih.gov/24781376Burden of community-acquired pneumonia in North American adults.
Thomas M File, Thomas J Marrie
https://pubmed.ncbi.nlm.nih.gov/20203464Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults.
Seema Jain, Wesley H Self, Richard G Wunderink...
https://pubmed.ncbi.nlm.nih.gov/26172429