Community-acquired PneumoniaPhase 4BICAPNCT00818610
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia
A Phase 4 study testing Beta lactam (amoxicillin / clav. acid OR cefuroxime) and Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin) in people with Community-acquired Pneumonia, run by Swiss National Fund for Scientific Research at 6 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Beta lactam (amoxicillin / clav. acid OR cefuroxime) and Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Jan 2009to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
HFR-Fribourg, Hôpital Cantonal
Fribourg, Canton of Fribourg, 1708
Hôpitaux Universitaires de Genève
Geneva, 1211
Hôpital Neuchâtelois - La Chaux-de-Fonds
La Chaux-de-Fonds, 2300
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Centre Hospitalier du Centre du Valais
Sion, Valais, 1950
Stadtspital Triemli
Zurich, Canton of Zurich, 8063
About this study
Official title: Beta-lactam Monotherapy Versus Beta-lactam - Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial.
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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Beta lactam (amoxicillin / clav. acid OR cefuroxime), Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)
- Keywords
- Community-acquired infections, Pneumonia, Clinical Stability, Antibiotics, Combination therapy, Atypical bacteria
- Medical subject headings
- Community-Acquired Pneumonia, Community-Acquired Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta lactam (amoxicillin / clav. acid OR cefuroxime)Drug
Also called Augmentin, Zinacef
1.2 g 4x/d OR 1.5 g 3x/d IV
Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)Drug
Also called Augmentin, Zinacef, Klacid
1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Not described Receives: Drug: Beta lactam (amoxicillin / clav. acid OR cefuroxime) |
| Bi-therapy | Active comparator | Not described Receives: Drug: Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Stability (hours)
Measured: 30 days
Secondary outcomes (2)
All cause mortality
Measured: in-hospital, at 30 and at 90 days
length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss National Fund for Scientific Research
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Garin Nicolas, Swiss National Fund for Scientific Research
- Investigators
- Arnaud Perrier, MD, Principal investigator, University of Geneva and University Hospital of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818610
- Sponsor's protocol ID
- 3200B0-120074/1
- Acronym
- BICAP
- Status last verified
- Apr 2013
- First submitted
- 6 Jan 2009
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35505308Garin 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.
PubMed 25286173
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-lactam Monotherapy Versus Beta-lactam - Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial.
- ClinicalTrials.gov ID
- NCT00818610
- Acronym / sponsor ID
- BICAP / 3200B0-120074/1
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community-acquired infections, Pneumonia, Clinical Stability, Antibiotics, Combination therapy, Atypical bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Swiss National Fund for Scientific ResearchUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta lactam (amoxicillin / clav. acid OR cefuroxime)Also: Augmentin, Zinacef1.2 g 4x/d OR 1.5 g 3x/d IV | Drug | Monotherapy |
| Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin)Also: Augmentin, Zinacef, Klacid1.2 g 4x/d OR 1.5 g 3x/d IV AND 0.5 g 2x/d IV/PO | Drug | Bi-therapy |
Primary outcome
Time to Clinical Stability (hours)
Time frame: 30 days
2 secondary outcomes
All cause mortality
Time frame: in-hospital, at 30 and at 90 days
length of stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Derived from this study: PubMed 35505308Chauffard 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.
- Derived from this study: PubMed 25286173Garin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Perrier, MD principal investigator
University of Geneva and University Hospital of Geneva
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta lactam (amoxicillin / clav. acid OR cefuroxime) and Beta-lactam (amoxicillin / clav. acid OR cefuroxime) AND macrolide (clarithromycin) in people with Community-acquired Pneumonia, run by Swiss National Fund for Scientific Research at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Stability (hours) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00818610, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.