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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000404-15 | EudraCT Number |
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CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria.
Three to five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.
The primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Shortened antibiotic treatment of 5 days |
|
| Control group | Active Comparator | Antibiotic treatment of 7 days or longer at the discretion of the treating physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Other | Shortened antibiotic treatment of 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day survival | within 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of antibiotic treatment | Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy | within 90 days |
| Length of hospital stay | Days from the date of hospital admission for pneumonia to the date of discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Bastrup Israelsen, MD | Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20729232 | Background | Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax. 2012 Jan;67(1):71-9. doi: 10.1136/thx.2009.129502. Epub 2010 Aug 20. | |
| 29020164 | Background | Ramirez JA, Wiemken TL, Peyrani P, Arnold FW, Kelley R, Mattingly WA, Nakamatsu R, Pena S, Guinn BE, Furmanek SP, Persaud AK, Raghuram A, Fernandez F, Beavin L, Bosson R, Fernandez-Botran R, Cavallazzi R, Bordon J, Valdivieso C, Schulte J, Carrico RM; University of Louisville Pneumonia Study Group. Adults Hospitalized With Pneumonia in the United States: Incidence, Epidemiology, and Mortality. Clin Infect Dis. 2017 Nov 13;65(11):1806-1812. doi: 10.1093/cid/cix647. |
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Trial data will be made available in anonymous form at public clinical trial databases when the trial has ended. Anonymized patient-level data and other detailed information will be provided by reasonable request to the principal investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2019 | Oct 25, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D001424 | Bacterial Infections |
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Control |
| Other |
Antibiotic treatment of 7 days or longer at the discretion of the treating physician |
|
| within 90 days |
| Antibiotic adverse events | Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia | within 90 days |
| Serious adverse events | Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines | within 90 days |
| Major complications | Number of participants with major complications, including pleural effusion, pleural empyema, lung abscess, respiratory failure, severe sepsis, renal failure, use of non-invasive or invasive ventilation, need for vasopressors, and intensive care unit (ICU) admission | within 90 days |
| Use of antimicrobials after discharge | Days of antibiotic treatment for any reason after hospital discharge | within 90 days |
| Post-discharge follow-up visits | Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner | within 90 days |
| Readmissions | Number of participants with readmissions for reasons related to or unrelated to pneumonia | days 30 and 90 |
| Mortality | Number of deaths by any cause | in-hospital, days 30 and 90 |
| Copenhagen |
| 2400 |
| Denmark |
| Gentofte Hospital | Gentofte Municipality | 2900 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Nordsjællands Hospital | Hillerød | 3400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| 28427381 | Background | Egelund GB, Jensen AV, Andersen SB, Petersen PT, Lindhardt BO, von Plessen C, Rohde G, Ravn P. Penicillin treatment for patients with Community-Acquired Pneumonia in Denmark: a retrospective cohort study. BMC Pulm Med. 2017 Apr 20;17(1):66. doi: 10.1186/s12890-017-0404-8. |
| 27455166 | Background | Uranga A, Espana PP, Bilbao A, Quintana JM, Arriaga I, Intxausti M, Lobo JL, Tomas L, Camino J, Nunez J, Capelastegui A. Duration of Antibiotic Treatment in Community-Acquired Pneumonia: A Multicenter Randomized Clinical Trial. JAMA Intern Med. 2016 Sep 1;176(9):1257-65. doi: 10.1001/jamainternmed.2016.3633. |
| 28666965 | Background | Aliberti S, Ramirez J, Giuliani F, Wiemken T, Sotgiu G, Tedeschi S, Carugati M, Valenti V, Marchioni M, Camera M, Piro R, Del Forno M, Milani G, Faverio P, Richeldi L, Deotto M, Villani M, Voza A, Tobaldini E, Bernardi M, Bellone A, Bassetti M, Blasi F. Individualizing duration of antibiotic therapy in community-acquired pneumonia. Pulm Pharmacol Ther. 2017 Aug;45:191-201. doi: 10.1016/j.pupt.2017.06.008. Epub 2017 Jun 27. |
| 12955634 | Background | Dunbar LM, Wunderink RG, Habib MP, Smith LG, Tennenberg AM, Khashab MM, Wiesinger BA, Xiang JX, Zadeikis N, Kahn JB. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003 Sep 15;37(6):752-60. doi: 10.1086/377539. Epub 2003 Aug 28. |
| 16763247 | Background | el Moussaoui R, de Borgie CA, van den Broek P, Hustinx WN, Bresser P, van den Berk GE, Poley JW, van den Berg B, Krouwels FH, Bonten MJ, Weenink C, Bossuyt PM, Speelman P, Opmeer BC, Prins JM. Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study. BMJ. 2006 Jun 10;332(7554):1355. doi: 10.1136/bmj.332.7554.1355. |
| 12570122 | Background | Torres A, Muir JF, Corris P, Kubin R, Duprat-Lomon I, Sagnier PP, Hoffken G. Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia. Eur Respir J. 2003 Jan;21(1):135-43. doi: 10.1183/09031936.03.00045202. |
| 17537866 | Background | File TM Jr, Mandell LA, Tillotson G, Kostov K, Georgiev O. Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study. J Antimicrob Chemother. 2007 Jul;60(1):112-20. doi: 10.1093/jac/dkm119. Epub 2007 May 30. |
| 28604925 | Background | Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. doi: 10.1001/jamainternmed.2017.1938. |
| 24237856 | Background | Huttner A, Harbarth S, Carlet J, Cosgrove S, Goossens H, Holmes A, Jarlier V, Voss A, Pittet D. Antimicrobial resistance: a global view from the 2013 World Healthcare-Associated Infections Forum. Antimicrob Resist Infect Control. 2013 Nov 18;2:31. doi: 10.1186/2047-2994-2-31. eCollection 2013. |
| 25261548 | Background | Pollack LA, Srinivasan A. Core elements of hospital antibiotic stewardship programs from the Centers for Disease Control and Prevention. Clin Infect Dis. 2014 Oct 15;59 Suppl 3(Suppl 3):S97-100. doi: 10.1093/cid/ciu542. |
| 27527659 | Background | Madaras-Kelly KJ, Burk M, Caplinger C, Bohan JG, Neuhauser MM, Goetz MB, Zhang R, Cunningham FE; Pneumonia Duration of Therapy Medication Utilization Evaluation Group. Total duration of antimicrobial therapy in veterans hospitalized with uncomplicated pneumonia: Results of a national medication utilization evaluation. J Hosp Med. 2016 Dec;11(12):832-839. doi: 10.1002/jhm.2648. Epub 2016 Aug 16. |
| 19926738 | Background | Aliberti S, Blasi F, Zanaboni AM, Peyrani P, Tarsia P, Gaito S, Ramirez JA. Duration of antibiotic therapy in hospitalised patients with community-acquired pneumonia. Eur Respir J. 2010 Jul;36(1):128-34. doi: 10.1183/09031936.00130909. Epub 2009 Nov 19. |
| 17765048 | Background | Li JZ, Winston LG, Moore DH, Bent S. Efficacy of short-course antibiotic regimens for community-acquired pneumonia: a meta-analysis. Am J Med. 2007 Sep;120(9):783-90. doi: 10.1016/j.amjmed.2007.04.023. |
| 18729535 | Background | Dimopoulos G, Matthaiou DK, Karageorgopoulos DE, Grammatikos AP, Athanassa Z, Falagas ME. Short- versus long-course antibacterial therapy for community-acquired pneumonia : a meta-analysis. Drugs. 2008;68(13):1841-54. doi: 10.2165/00003495-200868130-00004. |
| 17278083 | Background | Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available. |
| 11434826 | Background | Schrag SJ, Pena C, Fernandez J, Sanchez J, Gomez V, Perez E, Feris JM, Besser RE. Effect of short-course, high-dose amoxicillin therapy on resistant pneumococcal carriage: a randomized trial. JAMA. 2001 Jul 4;286(1):49-56. doi: 10.1001/jama.286.1.49. |
| 14625336 | Background | Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588. |
| 15546111 | Background | File TM Jr. Clinical efficacy of newer agents in short-duration therapy for community-acquired pneumonia. Clin Infect Dis. 2004 Sep 1;39 Suppl 3:S159-64. doi: 10.1086/421354. |
| 9459469 | Background | Guillemot D, Carbon C, Balkau B, Geslin P, Lecoeur H, Vauzelle-Kervroedan F, Bouvenot G, Eschwege E. Low dosage and long treatment duration of beta-lactam: risk factors for carriage of penicillin-resistant Streptococcus pneumoniae. JAMA. 1998 Feb 4;279(5):365-70. doi: 10.1001/jama.279.5.365. |
| 9600479 | Background | Halm EA, Fine MJ, Marrie TJ, Coley CM, Kapoor WN, Obrosky DS, Singer DE. Time to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines. JAMA. 1998 May 13;279(18):1452-7. doi: 10.1001/jama.279.18.1452. |
| 15578400 | Background | Menendez R, Torres A, Rodriguez de Castro F, Zalacain R, Aspa J, Martin Villasclaras JJ, Borderias L, Benitez Moya JM, Ruiz-Manzano J, Blanquer J, Perez D, Puzo C, Sanchez-Gascon F, Gallardo J, Alvarez CJ, Molinos L; Neumofail Group. Reaching stability in community-acquired pneumonia: the effects of the severity of disease, treatment, and the characteristics of patients. Clin Infect Dis. 2004 Dec 15;39(12):1783-90. doi: 10.1086/426028. Epub 2004 Nov 18. |
| 21919994 | Background | Choudhury G, Mandal P, Singanayagam A, Akram AR, Chalmers JD, Hill AT. Seven-day antibiotic courses have similar efficacy to prolonged courses in severe community-acquired pneumonia--a propensity-adjusted analysis. Clin Microbiol Infect. 2011 Dec;17(12):1852-8. doi: 10.1111/j.1469-0691.2011.03542.x. Epub 2011 Sep 15. |
| 37479519 | Derived | Israelsen SB, Tingsgard S, Thorlacius-Ussing L, Knudsen A, Lindegaard B, Johansen IS, Mygind LH, Ravn P, Benfield T. Short-course antibiotic therapy of 5 days in community-acquired pneumonia (CAP5): study protocol for a randomised controlled trial. BMJ Open. 2023 Jul 21;13(7):e069013. doi: 10.1136/bmjopen-2022-069013. |