Is beta-lactam therapy, until the patient has been afebrile for 48 hours (at least 5 days), sufficient for the treatment of community-acquired pneumonia?
| ISRCTN | ISRCTN14523624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14523624 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/01/2006
- Registration date
- 07/02/2006
- Last edited
- 22/03/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hans Holmberg
Scientific
Scientific
Department of Infectious Diseases
Orebro University Hospital
Orebro
SE-70185
Sweden
| Phone | +46 19 6021863 |
|---|---|
| hans.holmberg@orebroll.se |
Study information
| Study design | Prospective, randomised, open-label, multi-center (4 centres) study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PNEITID |
| Study objectives | 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(s) | Yes, by the Ethics Committee of the Orebro County Council, number 965-1999 (Sweden) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/1999 |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Adult patients with uncomplicated febrile community-acquired pneumonia, with chest X-ray infiltrates, who initially experience improvement with beta-lactam monotherapy |
| Key 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 |
| Date of first enrolment | 01/12/1999 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Infectious Diseases
Orebro
SE-70185
Sweden
SE-70185
Sweden
Sponsor information
The Research Committee of Orebro County Council (Sweden)
Research organisation
Research organisation
c/o Carl-Goran Ohlson MD, PhD
Assistant Professor
Clinical Research Centre
Orebro University Hospital
Orebro
SE-70185
Sweden
| Phone | +46 19 6022468 |
|---|---|
| carl-goran.ohlson@orebroll.se | |
"ROR" |
https://ror.org/00maqj547 |
Funders
Funder type
Research organisation
The Research Committee of Orebro County Council and The Orebro University Hospital Research Foundation (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Stralin et al. Clinical Infectious Diseases, ;38:766-7. | 01/03/2004 | Yes | No |
