Condition category
Respiratory
Date applied
19/01/2006
Date assigned
07/02/2006
Last edited
22/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hans Holmberg

ORCID ID

Contact details

Department of Infectious Diseases
Orebro University Hospital
Orebro
SE-70185
Sweden
+46 19 6021863
hans.holmberg@orebroll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PNEITID

Study hypothesis

Is beta-lactam therapy until the patient has been afebrile for 48 hours (and been treated for at least 5 days) as effective as beta-lactam therapy for 10 days in uncomplicated community-acquired pneumonia?

Ethics approval

Yes, by the Ethics Committee of the Orebro County Council, number 965-1999 (Sweden)

Study design

Prospective, randomised, open-label, multi-center (4 centres) study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Community-acquired pneumonia

Intervention

Patients who experience improvement with beta-lactam monotherapy are randomised, on treatment day 2-5, to receive this medication for either 10 days or until he/she has been afebrile for 48 hours (and has been treated for at least 5 days).

The body temperature is measured rectally three times daily and the patient is considered afebrile after a second consecutive temperature read at =/< 37.8 °C. Two weeks from the start of antibiotic treatment, a study nurse will have a telephone conversation with the patient, and four weeks from start of treatment, a follow-up visit, including a chest X-ray, is performed.

At hospital discharge, at the telephone conversation, and at the follow-up visit, the patient is asked if he/she has experienced cough or fever and is asked to describe his/her physical and mental condition. C-reactive protein and a serum for serological tests are taken on treatment day 3 and at the follow-up visit. Serological tests for Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydophila psittaci, and other respiratory viruses are performed.

At presentation, patients suitable for the study are subjected to cultures from blood, sputum, and nasopharyngeal secretions. Since 2005, the Binax NOW® Streptococcus pneumoniae urinary antigen test is also used to establish the pneumonia aetiology.


If a patient experiences fever, increasing dyspnoea, or increasing cough during the first month after inclusion in the study, careful analysis, including radiological investigations, microbiological investigations, and other laboratory investigations, is performed.

Intervention type

Drug

Phase

Not Specified

Drug names

beta-lactam

Primary outcome measures

1. Clinical cure at the four-week-visit
2. Recurrence of pneumonia within one month

Secondary outcome measures

1. Resolution of X-ray infiltrates
2. C-reactive protein-level at the four-week-visit
3. Reported fever, cough and of physical and mental condition at the telephone conversation or at the follow-up visit

Overall trial start date

01/12/1999

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with uncomplicated febrile community-acquired pneumonia, with chest X-ray infiltrates, who initially experience improvement with beta-lactam monotherapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Nursing home resident, hospitalisation during the preceding month, antibiotic treatment for any reason during the preceding week, ongoing antipyretic medication. Inability to make a telephone conversation or to attend to a follow-up visit

Recruitment start date

01/12/1999

Recruitment end date

31/05/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Infectious Diseases
Orebro
SE-70185
Sweden

Sponsor information

Organisation

The Research Committee of Orebro County Council (Sweden)

Sponsor details

c/o Carl-Goran Ohlson MD
PhD
Assistant Professor
Clinical Research Centre
Orebro University Hospital
Orebro
SE-70185
Sweden
+46 19 6022468
carl-goran.ohlson@orebroll.se

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

The Research Committee of Orebro County Council and The Orebro University Hospital Research Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Stralin et al. Clinical Infectious Diseases, 2004;38:766-7. http://www.journals.uchicago.edu/CID/journal/issues/v38n5/32666/32666.html

Publication citations

Additional files

Editorial Notes