Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)

NCT06804096 | Recruiting Phase 4 DMC

• 1 other identifier: BEX2410001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumonia, Community-Acquired; Bacterial Pneumonia

Keywords

CABP; Faropenem

Outcome Measures

Primary Outcomes (2)

• Clinical Cure Rate between two groups.

  The clinical cure rate will be defined as significant improvement of clinical signs and symptoms at the end of treatment or follow-up, without new onset of symptoms, any complications, or the need for further antimicrobial therapy.

  10-14 days

• Percentage of patients withdrawn from the study due to adverse events between two groups.

  To compare the percentage of patients withdrawn from the study due to adverse events between two groups.

  10-14 Days

Secondary Outcomes (5)

• Early Clinical Response (ECR) between two groups.

  3 - 4 days

• All-cause mortality between two groups

  10-14 days

• Number of patients who needed hospitalization in both groups

  28 days

• Number of patients who needed Intensive Care Unit (ICU) support in both groups.

  28 Days

• Frequency of Adverse Events & Serious Adverse Events between two groups.

  28 Days

Study Arms (2)

Arm 1

EXPERIMENTAL

Arm 1: Tab. Faropenem 200mg three times daily with standard care.

Drug: Faropenem

Arm 2

ACTIVE COMPARATOR

Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.

Drug: Co-amoxiclav; Drug: Clarithromycin 500 mg

Interventions

Faropenem DRUG

Tab. Faropenem 200mg three times daily

Arm 1

Co-amoxiclav DRUG

Tab. Co-Amoxiclav 625mg three times daily

Arm 2

Clarithromycin 500 mg DRUG

Tab. Clarithromycin 500mg two times daily

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Dr. Md. Alimur Reza: lead

Study Sites (2)

Popular Medical College & Hospital

Dhaka, Dhaka Division, 1205, Bangladesh

RECRUITING

Shaheed Suhrawardy Medical College & Hospital

Dhaka, Dhaka Division, 1205, Bangladesh

RECRUITING

Related Publications (9)

• 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.

  PMID: 15191378 BACKGROUND

• 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.

  PMID: 17402834 BACKGROUND

• 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.

  PMID: 18545744 BACKGROUND

• Morens DM, Taubenberger JK, Fauci AS. Predominant role of bacterial pneumonia as a cause of death in pandemic influenza: implications for pandemic influenza preparedness. J Infect Dis. 2008 Oct 1;198(7):962-70. doi: 10.1086/591708.

  PMID: 18710327 BACKGROUND

• 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.

  PMID: 21460288 BACKGROUND

• 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.

  PMID: 24130229 BACKGROUND

• 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.

  PMID: 24781376 BACKGROUND

• 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.

  PMID: 20203464 BACKGROUND

• 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.

  PMID: 26172429 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia, Bacterial

Interventions

fropenem; Amoxicillin-Potassium Clavulanate Combination; Clarithromycin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Lung Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Prof. Khan Abul Kalam Azad

  Popular Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Quazi Tarikul Islam, MBBS, FCPS, FACP (USA), FRCP,

  Popular Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)

CONTACT

+880-1727271414; prof.kakazad@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 31, 2025
• Study Start: February 20, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)