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

David Garcia Cinca

Status and phase: Unknown; Phase 4

Conditions: Community-acquired Pneumonia

Treatments: Drug: Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT03609099

NAC-ATB

Details and patient eligibility

About

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.

Enrollment: 424 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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424 participants in 2 patient groups

Moxifloxacin

Active Comparator group

Description:

Active treatment to patients treated during the 5 previous days.

Treatment:

Drug: Moxifloxacin

Placebo

Experimental group

Description:

Placebo treatment to patients treated during the 5 previous days.

Treatment:

Drug: Placebo