Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response

Phase 4

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Moxifloxacin; Drug: Placebo

• Registration Number: NCT03609099
• Lead Sponsor: David Garcia Cinca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Study Start: 2019-02-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-05
• Primary Completion: 2020-11-15
• Study Completion: 2021-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 424

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin	Active treatment to patients treated during the 5 previous days.
Placebo	Placebo	Placebo treatment to patients treated during the 5 previous days.

Primary Outcome Measures

Name	Time	Method
Rate of treatment failure	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

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

Trial Locations

Locations (5)

Hospital Galdakao-Usansolo; 🇪🇸 Galdakao, Bizkaia, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Universitario La Fe; 🇪🇸 València, Valencia, Spain

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Spain