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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
Stralin et al. Clinical Infectious Diseases, 2004;38:766-7. http://www.journals.uchicago.edu/CID/journal/issues/v38n5/32666/32666.html