NCT00818610

Brief Summary

The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
601

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

4 years

First QC Date

January 6, 2009

Last Update Submit

April 24, 2013

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired infectionsPneumoniaClinical StabilityAntibioticsCombination therapyAtypical bacteria

Outcome Measures

Primary Outcomes (1)

  • Time to Clinical Stability (hours)

    30 days

Secondary Outcomes (2)

  • All cause mortality

    in-hospital, at 30 and at 90 days

  • length of stay

    30 days

Study Arms (2)

Monotherapy

EXPERIMENTAL
Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime)

Bi-therapy

ACTIVE COMPARATOR
Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)

Interventions

Beta lactam (amoxicillin / clav. acid OR cefuroxime)DRUG

1.2 g 4x/d OR 1.5 g 3x/d IV

Also known as: Augmentin, Zinacef
Monotherapy
Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)DRUG

1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO

Also known as: Augmentin, Zinacef, Klacid
Bi-therapy

Eligibility Criteria

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

You may qualify if:

  • Age \>=18 years
  • New infiltrate on chest X-ray, unexplained by another disease process
  • Presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination
  • Need for hospitalization as defined by the emergency physician in charge of the patient

You may not qualify if:

  • Allergy to one of the study drugs
  • Pregnancy
  • Severe immunosuppression
  • Recent (\<14 d) hospitalization, or currently hospitalized since \> 48 hours
  • Residency in a nursing home
  • Previous use of more than 24 hours of any antibiotic
  • Severe community-acquired pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HFR-Fribourg, Hôpital Cantonal

Fribourg, Canton of Fribourg, 1708, Switzerland

Location

Stadtspital Triemli

Zurich, Canton of Zurich, 8063, Switzerland

Location

Centre Hospitalier du Centre du Valais

Sion, Valais, 1950, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Hôpital Neuchâtelois - La Chaux-de-Fonds

La Chaux-de-Fonds, 2300, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (2)

  • Chauffard A, Bridevaux PO, Carballo S, Prendki V, Reny JL, Stirnemann J, Garin N. Accuracy of a score predicting the presence of an atypical pathogen in hospitalized patients with moderately severe community-acquired pneumonia. BMC Infect Dis. 2022 May 3;22(1):424. doi: 10.1186/s12879-022-07423-1.

    PMID: 35505308DERIVED

  • Garin N, Genne D, Carballo S, Chuard C, Eich G, Hugli O, Lamy O, Nendaz M, Petignat PA, Perneger T, Rutschmann O, Seravalli L, Harbarth S, Perrier A. beta-Lactam monotherapy vs beta-lactam-macrolide combination treatment in moderately severe community-acquired pneumonia: a randomized noninferiority trial. JAMA Intern Med. 2014 Dec;174(12):1894-901. doi: 10.1001/jamainternmed.2014.4887.

    PMID: 25286173DERIVED

MeSH Terms

Conditions

Community-Acquired PneumoniaCommunity-Acquired InfectionsPneumonia

Interventions

beta-LactamsAmoxicillinCefuroximeAmoxicillin-Potassium Clavulanate CombinationMacrolidesClarithromycin

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesLung Diseases

Intervention Hierarchy (Ancestors)

LactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmpicillinPenicillin GPenicillinsCephalosporinsThiazinesClavulanic AcidClavulanic AcidsDrug CombinationsPharmaceutical PreparationsLactonesPolyketidesMacrocyclic CompoundsPolycyclic CompoundsErythromycin

Study Officials

  • Arnaud Perrier, MD

    University of Geneva and University Hospital of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate physician

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

April 25, 2013

Record last verified: 2013-04

Locations

CH(6)