Condition category
Respiratory
Date applied
18/01/2005
Date assigned
15/02/2005
Last edited
19/11/2007
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

Prof Beat Muller

ORCID ID

Contact details

University Hospital
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 2525
Happy.Mueller@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EKBB 232/03

Study information

Scientific title

Acronym

ProCAP-Study/ProResp II-Study

Study hypothesis

In patients with Community Acquired Pneumonia (CAP), guidelines recommend antibiotic treatment for 7 to 21 days. Procalcitonin is elevated in bacterial infections, and its dynamics have prognostic implications.

Objective:
To assess procalcitonin guidance for the initiation and duration of antibiotic therapy in community-acquired pneumonia.

Hypothesis:
Procalcitonin guidance could significantly shorten antibiotic duration with a similar clinical and laboratory outcome.

Ethics approval

The study was approved by the institutional review board of University Hospital Basel. Written, informed consent was obtained from all included patients or their legal representatives.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Community Acquired Pneumonia (CAP)

Intervention

Control group:
Receive antibiotics according to usual practice.

Intervention group:
In the procalcitonin group, antibiotic treatment was based on serum procalcitonin concentrations as follows:
1. Strongly discouraged: less than 0.1 µg/L
2. Discouraged: less than 0.25 µg/L
3. Encouraged: greater than 0.25 µg/L
4. Strongly encouraged: greater than 0.5 µg/L

Reevaluation of the clinical status and measurement of serum procalcitonin levels was recommended after 6 - 24 hours in all patients from whom antibiotics were withheld. Procalcitonin levels were reassessed after 4, 6, and 8 days. Antibiotics were discontinued on the basis of the procalcitonin cutoffs defined above. In patients with very high procalcitonin values on admission (e.g., greater than 10 µg/L), discontinuation of antibiotics was encouraged if levels decreased to levels less than 10% of the initial value (e.g., 1 µg/L, instead of less than 0.25 µg/L).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Total antibiotic use, recorded on days 4, 6, and 8 and at follow-up after 6 weeks.

Secondary outcome measures

Measures of laboratory and clinical outcomes, recorded on days 4, 6, and 8 and at follow-up after 6 weeks.

Overall trial start date

01/01/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

The criterion for inclusion in the study was a suspected CAP as the main diagnosis. This was defined as presence of a new infiltrate on chest X-ray accompanied by one or several acquired respiratory symptoms and signs:
1. Cough
2. Sputum production
3. Dyspnoea
4. Fever over 38.0°C
5. Auscultatory findings of abnormal breath sounds and rales
6. Leukocytosis more than 10 x 10^9 cells/L or leukopenia less than 4 x 10^9 cells/L in the absence of a hospital stay within 14 days before admission

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Cystic fibrosis or active tuberculosis
2. Immunocompromised patients, i.e. patients infected with Human Immunodeficiency Virus (HIV) infection and a CD4 count below 200
3. Neutropenic patients with a neutrophil count less than 500 x 10^9/ml
4. Under chemotherapy with neutrophils 500 - 1000 x 10^9/ml with an expected decrease to values less than 500 x 10^9/ml
5. Immunosuppressive therapy after bone marrow or solid organ transplantation
6. Nosocomial pneumonia

Recruitment start date

01/01/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 2525
Happy.Mueller@unibas.ch

Sponsor type

Hospital/treatment centre

Website

http://www.universitaetsspital-basel.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland):

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

1. Clinic of Pulmonary Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

2. Clinic of Endocrinology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

3. Emergency Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

4. Department of Internal Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

5. Department of Central Laboratories (infrastructure)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BRAHMS AG (Germany) - assay material

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

Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16805922
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17702966
3. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16603606

Publication citations

  1. Christ-Crain M, Morgenthaler NG, Stolz D, Müller C, Bingisser R, Harbarth S, Tamm M, Struck J, Bergmann A, Müller B, Pro-adrenomedullin to predict severity and outcome in community-acquired pneumonia [ISRCTN04176397]., Crit Care, 2006, 10, 3, R96, doi: 10.1186/cc4955.

  2. Christ-Crain M, Stolz D, Jutla S, Couppis O, Müller C, Bingisser R, Schuetz P, Tamm M, Edwards R, Müller B, Grossman AB, Free and total cortisol levels as predictors of severity and outcome in community-acquired pneumonia., Am. J. Respir. Crit. Care Med., 2007, 176, 9, 913-920, doi: 10.1164/rccm.200702-307OC.

  3. Christ-Crain M, Stolz D, Bingisser R, Müller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Müller B, Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial., Am. J. Respir. Crit. Care Med., 2006, 174, 1, 84-93, doi: 10.1164/rccm.200512-1922OC.

Additional files

Editorial Notes