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

Community-acquired Pneumonia Clinical Trial

— 2017-001406-15  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03609099
• Other study ID #: NAC-ATB
• Status: Recruiting
• Phase: Phase 4
• Start date: February 15, 2019
• Est. completion date: May 15, 2021

Study information

• Verified date: December 2019
• Source: Hospital Clinic of Barcelona
• Contact: Adrian Ceccato, MSD
• Phone: +34.93.227.54.00
• Email: aceccato[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: May 15, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Moxifloxacin
400 mg / day once a day oral treatment during 3 days.
• Placebo
once a day oral treatment during 3 days.

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital Galdakao-Usansolo	Galdakao	Bizkaia
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Universitario La Fe	València	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
David Garcia Cinca	Fundacion Clinic per a la Recerca Biomédica, Miquel Ferrer - Investigator Coordinator

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospital stay		up to 2 years
Secondary	Antibiotic-free days	Antibiotic-free days are defined as the number of days alive and free of antibiotics	Up to 28 days
Secondary	Proportion of adverse events		Up to 28 days
Secondary	Proportion of serious adverse events		Up to 28 days