Back to resultsAdequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response (2017-001406-15)
Primary Purpose
Community-acquired Pneumonia
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Moxifloxacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia
Eligibility 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.
Sites / Locations
- Hospital de MataróRecruiting
- Hospital Galdakao-UsansoloRecruiting
- Hospital Universitario La FeRecruiting
- Hospital Clínic i Provincial de BarcelonaRecruiting
- Hospital Universitario Virgen de ValmeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Moxifloxacin
Placebo
Arm Description
Active treatment to patients treated during the 5 previous days.
Placebo treatment to patients treated during the 5 previous days.
Outcomes
Primary Outcome Measures
Rate of treatment failure
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
Antibiotic-free days
Antibiotic-free days are defined as the number of days alive and free of antibiotics
Proportion of adverse events
Proportion of serious adverse events
Full Information
NCT ID
NCT03609099
First Posted
July 23, 2018
Last Updated
December 4, 2019
Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica, Miquel Ferrer - Investigator Coordinator
1. Study Identification
Unique Protocol Identification Number
NCT03609099
Brief Title
Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
Acronym
2017-001406-15
Official Title
Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
May 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca
Collaborators
Fundacion Clinic per a la Recerca Biomédica, Miquel Ferrer - Investigator Coordinator
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind treatment
Allocation
Randomized
Enrollment
424 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Active treatment to patients treated during the 5 previous days.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo treatment to patients treated during the 5 previous days.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Active treatment
Intervention Description
400 mg / day once a day oral treatment during 3 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once a day oral treatment during 3 days.
Primary Outcome Measure Information:
Title
Rate of treatment failure
Description
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.
Time Frame
during the 30 days after the day of hospital admission
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
up to 2 years
Title
Antibiotic-free days
Description
Antibiotic-free days are defined as the number of days alive and free of antibiotics
Time Frame
Up to 28 days
Title
Proportion of adverse events
Time Frame
Up to 28 days
Title
Proportion of serious adverse events
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian Ceccato, MSD
Phone
+34.93.227.54.00
Email
aceccato@clinic.cat
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Almirall, MD
Phone
+34.93.741.77.00
First Name & Middle Initial & Last Name & Degree
Jordi Almirall, MD
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
State/Province
Bizkaia
ZIP/Postal Code
48960
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro España, MD
Phone
+34.944.00.70.00
First Name & Middle Initial & Last Name & Degree
Pedro España, MD
Facility Name
Hospital Universitario La Fe
City
València
State/Province
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Menéndez, MD
Phone
+34.961.24.40.00
First Name & Middle Initial & Last Name & Degree
Rosario Menéndez, MD
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miquel Ferrer, MD
Phone
+34.227.54.00
First Name & Middle Initial & Last Name & Degree
Miquel Ferrer, MD
First Name & Middle Initial & Last Name & Degree
Adrian Ceccato, MD
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Alfageme, MD
Phone
+34.902.50.50.61
First Name & Middle Initial & Last Name & Degree
Inmaculada Alfageme, MD
12. IPD Sharing Statement
Learn more about this trial
Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
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