Pneumonia, Community-AcquiredPhase 4NCT06804096

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

A Phase 4 study testing Faropenem, Co-amoxiclav and Clarithromycin 500 mg in people with Pneumonia, Community-Acquired and Bacterial Pneumonia, run by Dr. Md. Alimur Reza at 2 sites in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pneumonia, Community-Acquired, Bacterial Pneumonia
What is being tested?: Faropenem, Co-amoxiclav and Clarithromycin 500 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 2 sitesBangladesh
Study dates: 20 Feb 2025to 26 Jan 2026
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 10Show fewer

Have radiographically documented bacterial pneumonia:
Infiltrates in a unilateral, lobar distribution
Diffuse opacities or white condensed area
The alveoli fill with white inflammatory fluid

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Bangladesh2 sites

Popular Medical College & Hospital
Dhaka, Dhaka Division, 1205
Shaheed Suhrawardy Medical College & Hospital
Dhaka, Dhaka Division, 1205

Other trials in Bangladesh

About this study

Official title: Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial

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
Being tested: Faropenem, Co-amoxiclav, Clarithromycin 500 mg
Keywords: CABP, Faropenem
Medical subject headings: Community-Acquired Pneumonia, Pneumonia, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FaropenemDrug
Tab. Faropenem 200mg three times daily
Co-amoxiclavDrug
Tab. Co-Amoxiclav 625mg three times daily
Clarithromycin 500 mgDrug
Tab. Clarithromycin 500mg two times daily

Study groups in NCT06804096
Study group	Role	What they receive
Arm 1	Experimental	Arm 1: Tab. Faropenem 200mg three times daily with standard care. Receives: 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. Receives: Drug: Co-amoxiclav; Drug: Clarithromycin 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 10-14 Days

Secondary outcomes (5)

Early Clinical Response (ECR) between two groups.
ECR will be defined as at least one improvement in the symptom mentioned below within 3 ± 1 days after the first dose of the study drug.
1. Fever
2. Decreased shortness of breath.
3. Decreased chest pain.
4. Decreased cough.
5. Decreased sputum/mucous production.
6. Sense of wellbeing.]
Measured: 3 - 4 days
All-cause mortality between two groups
To compare the all-cause mortality rate between two groups
Measured: 10-14 days
Number of patients who needed hospitalization in both groups
Measured: 28 days
Number of patients who needed Intensive Care Unit (ICU) support in both groups.
Measured: 28 Days
Frequency of Adverse Events & Serious Adverse Events between two groups.
Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 202526 Jan 2026

First posted31 Jan 2025
Study start20 Feb 2025
Primary completion12 Jan 2026
Study completion26 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Pneumonia, Community-AcquiredStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06804096
Sponsor's protocol ID: BEX2410001
Status last verified: Aug 2026
First submitted: 26 Jan 2025
Last updated: 4 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 15191378
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.
PubMed 17402834
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.
PubMed 18545744
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.
PubMed 18710327
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.
PubMed 21460288
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.
PubMed 24130229
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.
PubMed 24781376
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.
PubMed 20203464
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.
PubMed 26172429
Azad KAK, Islam QT, Ahasan HAMN, Zahiruddin M, Islam MR, Yasmin R, Mowla SGM, Elahi KMA, Reza ST, Reza MA. Efficacy and Safety of Faropenem in Bangladeshi Adults With Community-Acquired Pneumonia: A Randomized Controlled Trial. Cureus. 2026 Nov 1;18(11):e118941. doi: 10.7759/cureus.118941. eCollection 2026 Nov.
PubMed 42973964

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06804096
Acronym / sponsor ID: BEX2410001
Conditions: Pneumonia, Community-Acquired, Bacterial Pneumonia
Keywords: CABP, Faropenem
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Dr. Md. Alimur RezaIndustry (pharma, biotech, devices)
Study start: 20 Feb 2025 (actual)
Primary completion: 12 Jan 2026 (actual)
Study completion: 26 Jan 2026 (actual)
First posted: 31 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: FaropenemArm 1: Tab. Faropenem 200mg three times daily with standard care.
Arm 2	Active comparator	Drug: Co-amoxiclav, Drug: Clarithromycin 500 mgArm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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):
Have radiographically documented bacterial pneumonia:

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FaropenemTab. Faropenem 200mg three times daily	Drug	Arm 1
Co-amoxiclavTab. Co-Amoxiclav 625mg three times daily	Drug	Arm 2
Clarithromycin 500 mgTab. Clarithromycin 500mg two times daily	Drug	Arm 2

Primary outcome

Clinical Cure Rate between two groups.
Time frame: 10-14 days
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.
Percentage of patients withdrawn from the study due to adverse events between two groups.
Time frame: 10-14 Days
To compare the percentage of patients withdrawn from the study due to adverse events between two groups.

5 secondary outcomes

Early Clinical Response (ECR) between two groups.
Time frame: 3 - 4 days
All-cause mortality between two groups
Time frame: 10-14 days
Number of patients who needed hospitalization in both groups
Time frame: 28 days
Number of patients who needed Intensive Care Unit (ICU) support in both groups.
Time frame: 28 Days
Frequency of Adverse Events & Serious Adverse Events between two groups.
Time frame: 28 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Background: PubMed 15191378Lode 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.
Background: PubMed 17402834Schurek 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.
Background: PubMed 18545744Rudan 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.
Background: PubMed 18710327Morens 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.
Background: PubMed 21460288Bartlett JG. Diagnostic tests for agents of community-acquired pneumonia. Clin Infect Dis. 2011 May;52 Suppl 4:S296-304. doi: 10.1093/cid/cir045.
Background: PubMed 24130229Torres 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.
Background: PubMed 24781376Peto 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.
Background: PubMed 20203464File 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.
Background: PubMed 26172429Jain 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.
Derived from this study: PubMed 42973964Azad KAK, Islam QT, Ahasan HAMN, Zahiruddin M, Islam MR, Yasmin R, Mowla SGM, Elahi KMA, Reza ST, Reza MA. Efficacy and Safety of Faropenem in Bangladeshi Adults With Community-Acquired Pneumonia: A Randomized Controlled Trial. Cureus. 2026 Nov 1;18(11):e118941. doi: 10.7759/cureus.118941. eCollection 2026 Nov.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Khan Abul Kalam Azad principal investigator

Popular Medical College Hospital

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

Popular Medical College Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Faropenem, Co-amoxiclav and Clarithromycin 500 mg in people with Pneumonia, Community-Acquired and Bacterial Pneumonia, run by Dr. Md. Alimur Reza at 2 sites in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Cure Rate between two groups. (time frame: 10-14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06804096, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.