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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Arm 1: Tab. Faropenem 200mg three times daily with standard care. |
|
| Arm 2 | Active Comparator | Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faropenem | Drug | Tab. Faropenem 200mg three times daily |
| |
| Co-amoxiclav |
| Measure | Description | Time Frame |
|---|---|---|
| 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| Percentage of patients withdrawn from the study due to adverse events between two groups. | To compare the percentage of patients withdrawn from the study due to adverse events between two groups.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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 3 - 4 days |
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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):
Have radiographically documented bacterial pneumonia:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA) | Contact | +880-1727271414 | prof.kakazad@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Popular Medical College & Hospital | Recruiting | Dhaka | Dhaka Division | 1205 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15191378 | Background | 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. | |
| 17402834 | Background |
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| Drug |
Tab. Co-Amoxiclav 625mg three times daily |
|
| Clarithromycin 500 mg | Drug | Tab. Clarithromycin 500mg two times daily |
|
| All-cause mortality between two groups | To compare the all-cause mortality rate 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 |
| Shaheed Suhrawardy Medical College & Hospital | Recruiting | Dhaka | Dhaka Division | 1205 | Bangladesh |
|
| 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. |
| 18545744 | 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. |
| 18710327 | 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. |
| 21460288 | 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. |
| 24130229 | 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. |
| 24781376 | 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. |
| 20203464 | 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. |
| 26172429 | 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. |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C107057 | fropenem |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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