Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response (2017-001406-15)

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.

Study Overview

• Status: Unknown
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Moxifloxacin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 424
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Adrian Ceccato, MSD; Phone Number: +34.93.227.54.00; Email: aceccato@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic i Provincial de Barcelona
    • Contact: Miquel Ferrer, MD; Phone Number: +34.227.54.00
    • Principal Investigator: Miquel Ferrer, MD
    • Sub-Investigator: Adrian Ceccato, MD
  • Sevilla, Spain, 41001
    • Recruiting
    • Hospital Universitario Virgen de Valme
    • Contact: Inmaculada Alfageme, MD; Phone Number: +34.902.50.50.61
    • Principal Investigator: Inmaculada Alfageme, MD
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Recruiting
      • Hospital de Mataro
      • Contact: Jordi Almirall, MD; Phone Number: +34.93.741.77.00
      • Principal Investigator: Jordi Almirall, MD
  • Bizkaia
    • Galdakao, Bizkaia, Spain, 48960
      • Recruiting
      • Hospital Galdakao-Usansolo
      • Contact: Pedro España, MD; Phone Number: +34.944.00.70.00
      • Principal Investigator: Pedro España, MD
  • Valencia
    • València, Valencia, Spain, 46026
      • Recruiting
      • Hospital Universitario La Fe
      • Contact: Rosario Menéndez, MD; Phone Number: +34.961.24.40.00
      • Principal Investigator: Rosario Menéndez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Moxifloxacin; Active treatment to patients treated during the 5 previous days.	Drug: Moxifloxacin; 400 mg / day once a day oral treatment during 3 days.; Other Names: Active treatment
EXPERIMENTAL: Placebo; Placebo treatment to patients treated during the 5 previous days.	Drug: Placebo; once a day oral treatment during 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during the 30 days after the day of hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		up to 2 years
Antibiotic-free days	Antibiotic-free days are defined as the number of days alive and free of antibiotics	Up to 28 days
Proportion of adverse events		Up to 28 days
Proportion of serious adverse events		Up to 28 days

Collaborators and Investigators

• Sponsor: David Garcia Cinca
• Collaborators: Fundacion Clinic per a la Recerca Biomédica; Miquel Ferrer - Investigator Coordinator

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ANTICIPATED): November 15, 2020
• Study Completion (ANTICIPATED): May 15, 2021

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: NAC-ATB

Drug and device information, study documents

• 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