Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response (2017-001406-15)
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| ClinicalTrials.gov Identifier: NCT03609099 |
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Recruitment Status : Unknown
Verified December 2019 by David Garcia Cinca, Hospital Clinic of Barcelona.
Recruitment status was: Recruiting
First Posted : August 1, 2018
Last Update Posted : December 5, 2019
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Sponsor:
David Garcia Cinca
Collaborators:
Fundacion Clinic per a la Recerca Biomédica
Miquel Ferrer - Investigator Coordinator
Information provided by (Responsible Party):
David Garcia Cinca, Hospital Clinic of Barcelona
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Brief Summary:
Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Community-acquired Pneumonia | Drug: Moxifloxacin Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 424 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Double blind treatment |
| Primary Purpose: | Treatment |
| Official Title: | Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response |
| Actual Study Start Date : | February 15, 2019 |
| Estimated Primary Completion Date : | November 15, 2020 |
| Estimated Study Completion Date : | May 15, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Moxifloxacin
Active treatment to patients treated during the 5 previous days.
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Drug: Moxifloxacin
400 mg / day once a day oral treatment during 3 days.
Other Name: Active treatment |
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Experimental: Placebo
Placebo treatment to patients treated during the 5 previous days.
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Drug: Placebo
once a day oral treatment during 3 days. |
Primary Outcome Measures :
- Rate of treatment failure [ Time Frame: during the 30 days after the day of hospital admission ]Treatment failure is defined as the appearance of any of the following manifestations: death from any cause, hospital readmission for any cause or restart of antibiotic treatment for any reason.
Secondary Outcome Measures :
- Length of hospital stay [ Time Frame: up to 2 years ]
- Antibiotic-free days [ Time Frame: Up to 28 days ]Antibiotic-free days are defined as the number of days alive and free of antibiotics
- Proportion of adverse events [ Time Frame: Up to 28 days ]
- Proportion of serious adverse events [ Time Frame: Up to 28 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients of both sexes older than 18 years
- Hospitalized patients diagnosed with CAP: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (> 38 ° C), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
- That they present a PSI score class IV or V.
- Patients who have received adequate antibiotic treatment according to clinical guidelines (SEPAR, ATS) ((1,8,19)) from the first hour of admission to the emergency room.
- Patients who reach clinical stability: temperature ≤37.2 ºC, heart rate ≤100 beats / min, respiratory rate ≤24 breaths / min, systolic blood pressure> 90 mmHg; oxygen saturation> 90%; or oxygen blood pressure> 60 mmHg (15) before the fourth day.
- Signature of informed consent.
Exclusion Criteria:
- Immunosuppression: Co infection with HIV and presence of AIDS, treatment with neutropenic effect or have received immunosuppressive treatment for any reason. Patients that are in chronic use of corticosteroids as prednisone or its equivalent with > 10 mg / day for 14 days.
- Patients hospitalized in the previous 14 days.
- Patients with pleural effusion
- Suspected multiresistant germs of any cause.
- Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
- Pregnancy or lactation.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609099
Contacts
| Contact: Adrian Ceccato, MSD | +34.93.227.54.00 | aceccato@clinic.cat |
Locations
| Spain | |
| Hospital de Mataró | Recruiting |
| Mataró, Barcelona, Spain, 08304 | |
| Contact: Jordi Almirall, MD +34.93.741.77.00 | |
| Principal Investigator: Jordi Almirall, MD | |
| Hospital Galdakao-Usansolo | Recruiting |
| Galdakao, Bizkaia, Spain, 48960 | |
| Contact: Pedro España, MD +34.944.00.70.00 | |
| Principal Investigator: Pedro España, MD | |
| Hospital Universitario La Fe | Recruiting |
| València, Valencia, Spain, 46026 | |
| Contact: Rosario Menéndez, MD +34.961.24.40.00 | |
| Principal Investigator: Rosario Menéndez, MD | |
| Hospital Clínic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Miquel Ferrer, MD +34.227.54.00 | |
| Principal Investigator: Miquel Ferrer, MD | |
| Sub-Investigator: Adrian Ceccato, MD | |
| Hospital Universitario Virgen de Valme | Recruiting |
| Sevilla, Spain, 41001 | |
| Contact: Inmaculada Alfageme, MD +34.902.50.50.61 | |
| Principal Investigator: Inmaculada Alfageme, MD | |
Sponsors and Collaborators
David Garcia Cinca
Fundacion Clinic per a la Recerca Biomédica
Miquel Ferrer - Investigator Coordinator
| Responsible Party: | David Garcia Cinca, Study Applicant, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT03609099 |
| Other Study ID Numbers: |
NAC-ATB |
| First Posted: | August 1, 2018 Key Record Dates |
| Last Update Posted: | December 5, 2019 |
| Last Verified: | December 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Moxifloxacin Anti-Bacterial Agents |
Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |