Pneumonia, BacterialPhase 2NCT00111644
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
A Phase 2 study testing Ceftriaxone and beta-lactam in people with Pneumonia, Bacterial, run by Hoffmann-La Roche at 49 sites in 11 countries.
Trial summary
This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- Ceftriaxone and beta-lactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 49 sitesin 11 countries
- Study dates
- Mar 2005to Jan 2007
- Phase
- Phase 2
- 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
- male or female patients at least 18 years of age;
- hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
- fever;
- new or increased productive cough;
- chest pain, shortness of breath, or rapid breathing.
Who cannot join
- requiring intubation or ventilation;
- nursing home or extended care within 60 days before study;
- concomitant bacterial infection requiring antibiotics;
- long-term immunosuppressive therapy.
Trial locations and contacts
49 sites in 11 countries.
49 sites in 11 countries
Argentina13 sites
Study site
Buenos Aires, 1180
Study site
Buenos Aires, 1282
Study site
Buenos Aires, 1427
Study site
Buenos Aires, 1602
Study site
Buenos Aires, 1657
Study site
Buenos Aires, 1888
Study site
Buenos Aires, BUE1430
Study site
Ciudadela, 1702
Study site
Córdoba, 5000
Study site
Córdoba, X5004CDT
Study site
Granadero Baigorria, 2152
Study site
Paraná, 3100
Study site
Rosario, S2000DSV
United States6 sites
Study site
Butte, Montana, 59701
Study site
Detroit, Michigan, 48201
Study site
Holmdel, New Jersey, 07733
Study site
New Orleans, Louisiana, 70112
Study site
Shreveport, Louisiana, 71105
Study site
Winston-Salem, North Carolina, 27103
Romania6 sites
Study site
Bucharest, 030303
Study site
Bucharest, 21105
Study site
Bucharest, 21659
Study site
Bucharest
Study site
Constanța, 8700
Study site
Craiova, 200515
Bulgaria4 sites
Study site
Rousse, 7002
Study site
Sofia, 1233
Study site
Sofia, 1431
Study site
Sofia, 1606
Hungary4 sites
Study site
Budapest, 1529
Study site
Nyíregyháza, 4400
Study site
Törökbálint, 2045
Study site
Zalaegerszeg, 8900
Slovakia4 sites
Study site
Banská Bystrica, 975 17
Study site
Nitra, 949 88
Study site
Nitra, 950 01
Study site
Poprad, 058 87
Latvia3 sites
Study site
Daugavpils, 5417
Study site
Riga, 1038
Study site
Riga, LV-1002
Lithuania3 sites
Study site
Kaunas, 3000
Study site
Klaipėda, 92231
Study site
Vilnius, 08661
About this study
Official title: A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia
This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
- Conditions
- Pneumonia, Bacterial
- Being tested
- Ceftriaxone, beta-lactam
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
1000mg iv daily
beta-lactamDrug
750mg iv q 23h for 3-14 days
beta-lactamDrug
1500mg iv q 12h for 3-14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: beta-lactam |
| 2 | Experimental | Not described Receives: Drug: beta-lactam |
| 3 | Active comparator | Not described Receives: Drug: Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate\n\n
Measured: End of study visit (7-10 days after end of treatment)
Secondary outcomes (1)
Adverse events, vital signs, laboratory parameters\n
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2005 (estimated)
- Study startMar 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111644
- Sponsor's protocol ID
- WI18273
- Status last verified
- Nov 2016
- First submitted
- 24 May 2005
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT00111644
- Acronym / sponsor ID
- WI18273
- Conditions
- Pneumonia, Bacterial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 25 May 2005 (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.
This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: beta-lactam |
| 2 | Experimental | Drug: beta-lactam |
| 3 | Active comparator | Drug: Ceftriaxone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female patients at least 18 years of age;
- hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
- fever;
- new or increased productive cough;
- chest pain, shortness of breath, or rapid breathing.
Key exclusion criteria (4 listed)
- requiring intubation or ventilation;
- nursing home or extended care within 60 days before study;
- concomitant bacterial infection requiring antibiotics;
- long-term immunosuppressive therapy.
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 |
|---|---|---|
| Ceftriaxone1000mg iv daily | Drug | 3 |
| beta-lactam750mg iv q 23h for 3-14 days | Drug | 1 |
| beta-lactam1500mg iv q 12h for 3-14 days | Drug | 2 |
Primary outcome
Clinical cure rate\n\n
Time frame: End of study visit (7-10 days after end of treatment)
1 secondary outcome
Adverse events, vital signs, laboratory parameters\n
Time frame: Throughout study
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
49 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceftriaxone and beta-lactam in people with Pneumonia, Bacterial, run by Hoffmann-La Roche at 49 sites in 11 countries.
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 5 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Argentina, United States, Romania, Bulgaria, Hungary and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical cure rate\n\n (time frame: End of study visit (7-10 days after end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.