Clinical trial NCT06804096: Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)
Official title: Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pneumonia, Community-Acquired
Bacterial Pneumonia
Keywords: CABP
Faropenem
Lead sponsor: Beximco Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. The first arm will receive faropenem at a dosage of 200 mg administered three times daily for a duration of seven days. The second arm will receive co-amoxiclav 625 mg, also three times daily, along with clarithromycin 500 mg, administered twice daily for seven days. All participants included in the study will undergo follow-up assessments over a period of four weeks. This research aims to provide valuable insights regarding the potential role of faropenem, thereby enhancing clinical outcomes and informing antibiotic stewardship in a region significantly burdened by CABP and characterized by limited treatment alternatives.


Eligibility criteria: Inclusion 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):

  1. Fever (body temperature \> 38.0 °C (100.4 °F) measured orally)
  2. Shortness of breath
  3. New onset or increased cough with or without sputum production.
  4. Chest pain.
* Have radiographically documented bacterial pneumonia:

  1. Infiltrates in a unilateral, lobar distribution
  2. Diffuse opacities or white condensed area
  3. The alveoli fill with white inflammatory fluid

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clinical Cure Rate between two groups.
timeFrame: 10-14 days
measure: Percentage of patients withdrawn from the study due to adverse events between two groups.
timeFrame: 10-14 Days
Secondary outcomes:
measure: Early Clinical Response (ECR) between two groups.
timeFrame: 3 - 4 days
measure: All-cause mortality between two groups
timeFrame: 10-14 days
measure: Number of patients who needed hospitalization in both groups
timeFrame: 28 days
measure: Number of patients who needed Intensive Care Unit (ICU) support in both groups.
timeFrame: 28 Days
measure: Frequency of Adverse Events & Serious Adverse Events between two groups.
timeFrame: 28 Days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Popular Medical College & Hospital
city: Dhaka
country: Bangladesh
facility: Shaheed Suhrawardy Medical College & Hospital
Study officials:
affiliation: Popular Medical College Hospital
name: Prof. Khan Abul Kalam Azad
role: PRINCIPAL_INVESTIGATOR
affiliation: Popular Medical College Hospital
name: Prof. Quazi Tarikul Islam, MBBS, FCPS, FACP (USA), FRCP,
role: STUDY_DIRECTOR
References:
citation: Lode H, Magyar P, Muir JF, Loos U, Kleutgens K; International Gatifloxacin Study Group. Once-daily oral gatifloxacin vs three-times-daily co-amoxiclav in the treatment of patients with community-acquired pneumonia. Clin Microbiol Infect. 2004 Jun;10(6):512-20. doi: 10.1111/j.1469-0691.2004.00875.x.
citation: Schurek KN, Wiebe R, Karlowsky JA, Rubinstein E, Hoban DJ, Zhanel GG. Faropenem: review of a new oral penem. Expert Rev Anti Infect Ther. 2007 Apr;5(2):185-98. doi: 10.1586/14787210.5.2.185.
citation: Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ. 2008 May;86(5):408-16. doi: 10.2471/blt.07.048769.
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citation: Bartlett JG. Diagnostic tests for agents of community-acquired pneumonia. Clin Infect Dis. 2011 May;52 Suppl 4:S296-304. doi: 10.1093/cid/cir045.
citation: Torres A, Peetermans WE, Viegi G, Blasi F. Risk factors for community-acquired pneumonia in adults in Europe: a literature review. Thorax. 2013 Nov;68(11):1057-65. doi: 10.1136/thoraxjnl-2013-204282.
citation: Peto L, Nadjm B, Horby P, Ngan TT, van Doorn R, Van Kinh N, Wertheim HF. The bacterial aetiology of adult community-acquired pneumonia in Asia: a systematic review. Trans R Soc Trop Med Hyg. 2014 Jun;108(6):326-37. doi: 10.1093/trstmh/tru058. Epub 2014 Apr 29.
citation: File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010 Mar;122(2):130-41. doi: 10.3810/pgm.2010.03.2130.
citation: Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, Reed C, Grijalva CG, Anderson EJ, Courtney DM, Chappell JD, Qi C, Hart EM, Carroll F, Trabue C, Donnelly HK, Williams DJ, Zhu Y, Arnold SR, Ampofo K, Waterer GW, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, McCullers JA, Pavia AT, Edwards KM, Finelli L; CDC EPIC Study Team. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. N Engl J Med. 2015 Jul 30;373(5):415-27. doi: 10.1056/NEJMoa1500245. Epub 2015 Jul 14.