NCT03609099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
424

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2019

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

July 23, 2018

Last Update Submit

December 4, 2019

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Length of hospital stay

    up to 2 years

  • Antibiotic-free days

    Up to 28 days

  • Proportion of adverse events

    Up to 28 days

  • Proportion of serious adverse events

    Up to 28 days

Study Arms (2)

Moxifloxacin

ACTIVE COMPARATOR

Active treatment to patients treated during the 5 previous days.

Drug: Moxifloxacin

Placebo

EXPERIMENTAL

Placebo treatment to patients treated during the 5 previous days.

Drug: Placebo

Interventions

MoxifloxacinDRUG

400 mg / day once a day oral treatment during 3 days.

Also known as: Active treatment
Moxifloxacin
PlaceboDRUG

once a day oral treatment during 3 days.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

RECRUITING

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, 41001, Spain

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Adrian Ceccato, MSD

CONTACT

+34.93.227.54.00aceccato@clinic.cat

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blind treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Applicant

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 1, 2018

Study Start

February 15, 2019

Primary Completion

November 15, 2020

Study Completion

May 15, 2021

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

ES(5)