Efficacy of High Doses Penicillin V Versus High Doses Amoxicillin in the Treatment of Non-severe Pneumonia.

NCT03208361 | Terminated Phase 3

• 2 other identifiers: IJG-PEN-20122012-003511-63
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate wether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP).

Conditions

Community-acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (5)

• Disappearance of fever

  Disappearance of fever (included in the general definition of Clinical Cure)

  14 days after inclusion

• Disappearance or improvement of cough

  Disappearance or improvement of cough (included in the general definition of Clinical Cure)

  14 days after inclusion

• Improvement of general condition

  Improvement of general condition (included in the general definition of Clinical Cure)

  14 days after inclusion

• Disappearance or reduction of auscultation of crackles

  Disappearance or reduction of auscultation of crackles (included in the general definition of Clinical Cure)

  14 days after inclusion

• No other antimicrobial treatment necessary

  No other antimicrobial treatment necessary (included in the general definition of Clinical Cure

  14 days after inclusion

Secondary Outcomes (9)

• Disappearance of fever

  30 days after inclusion

• disappearance or improvement of cough

  30 days after inclusion

• improvement of general condition

  30 days after inclusion

• disappearance or reduction of auscultation of crackles

  30 days after inclusion

• No other antimicrobial treatment necessary

  30 days after inclusion

Study Arms (2)

Penicillin V

EXPERIMENTAL

Penicillin V, 1600000 IU every 8h during 10 days.

Drug: Penicillin V

Amoxicillin

ACTIVE COMPARATOR

Amoxicillin, 1 g every 8h during 10 days.

Drug: Amoxicillin

Interventions

Penicillin V DRUG

Penicillin V

Amoxicillin DRUG

Amoxicillin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years to 75 years (inclusive).
• Signs and symptoms of lower respiratory tract infection.
• Signature of informed consent.

You may not qualify if:

• Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at the discretion of the investigator
• Respiratory rate\> 30 breaths / minute
• Heart rate\> 125 beats / minute
• Systolic blood pressure \<90 mm ??Hg or diastolic BP \<60 mm Hg
• Hypersensitivity to beta-Lactamics
• O2 saturation \<92%
• Axillary temperature\> 40 ° C
• bronchial Asthma
• Pregnancy or lactation
• Significant comorbidities: renal failure, liver cirrhosis, heart failure, chronic obstructive pulmonary disease, ischemic heart disease diagnosed less than 6 months, stroke diagnosed less than 6 months ago and / or type 1 diabetes mellitus
• Significant alteration in chest radiography: alveolar infiltrates in more than one lobe or bilateral pleural effusion or pulmonary cavitation
• Problems to meet the treatment at home: sociopathy or psychiatric problems, drug and alcohol addiction, or, an unsuitable family environment
• Lack of tolerance to oral therapy: presence of nausea and vomiting, gastrectomy, post-surgery or frank diarrhea
• Immunosuppression: chronic HIV infection, transplant, neutropenic, or, patients receiving immunosuppressive therapy
• active malignancy

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

IDIAP Jordi Gol

Barcelona, 08007, Spain

Location

Related Publications (3)

• Aubier M, Verster R, Regamey C, Geslin P, Vercken JB. Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Sparfloxacin European Study Group. Clin Infect Dis. 1998 Jun;26(6):1312-20. doi: 10.1086/516366.

  PMID: 9636854 BACKGROUND

• Petitpretz P, Arvis P, Marel M, Moita J, Urueta J; CAP5 Moxifloxacin Study Group. Oral moxifloxacin vs high-dosage amoxicillin in the treatment of mild-to-moderate, community-acquired, suspected pneumococcal pneumonia in adults. Chest. 2001 Jan;119(1):185-95. doi: 10.1378/chest.119.1.185.

  PMID: 11157603 BACKGROUND

• Llor C, Arranz J, Morros R, Garcia-Sangenis A, Pera H, Llobera J, Guillen-Sola M, Carandell E, Ortega J, Hernandez S, Miravitlles M. Efficacy of high doses of oral penicillin versus amoxicillin in the treatment of adults with non-severe pneumonia attended in the community: study protocol for a randomised controlled trial. BMC Fam Pract. 2013 Apr 17;14:50. doi: 10.1186/1471-2296-14-50.

  PMID: 23594463 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Penicillin V; Amoxicillin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G

Study Officials

• Car Llor Vilà, MD, PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Penicillin V (phenoxymethylpenicillin) Arm 2: Amoxicillin (control)

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 5, 2017
• Study Start: November 5, 2013
• Primary Completion: March 29, 2016
• Study Completion: April 21, 2016
• Last Updated: July 5, 2017

Record last verified: 2017-06

Locations

ES (1)