Community Acquired PneumoniaPhase 4PENCAPNCT00887276
Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
A Phase 4 study testing Moxifloxacin and Ampicillin;Amoxicillin in people with Community Acquired Pneumonia, run by University of Ulm at 8 sites in Germany.
Trial summary
The purpose of this study is to prove the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe 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?
- Moxifloxacin and Ampicillin;Amoxicillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 8 sitesGermany
- Study dates
- Nov 2008to Jan 2011
- 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
- Men or women older than 18 years with signed informed consent
- Women in a childbearing age with sufficient conception protection or if necessary negative pregnancy test
- Infiltrates appeared newly in the x-ray thorax
- Breath-conditioned chest pain
- At least two of the following clinical symptoms of a pneumonia:
- cough which is newly appeared or increasing,
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- dyspnea
- mucopurulent or purulent sputum,
- fever (body temperature >= 37.8 degrees Celsius auricalary and/or >= 38,3°C rectal), positive auscultation
- Negative legionella antigen test in the urine
- CRB-65-Index < 3
Who cannot join
- Hospitalization within the last 28 days (except for the last 72 h)
- Participation in another therapy study within the last 4 weeks with studies admission
- intake of an antibiotic longer than 24 hrs within the last 72 hours before studies admission
- Patients in the pregnancy and nursing phase
- Existence of contraindications opposite the examining preparations or other B-Lactam antibiotics or fluorochinolons
- Patients with a CURB-Index >= 3
Show all 9Show fewer
- Patients with suspicion of retrostenotic Pneumonia because of bronchial obstruction
- Patients with suspicion of nosocomial Pneumonia
- Patients with an infection by a known or suspected resistant pathogene
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Charité - Universitätsmedizin Berlin ,Campus Virchow-Klinikum ,Medizinische Klinik : Infektiologie u. Pneumologie
Berlin
HELIOS-Klinikum Emil von Behring ,Lungenklinik Heckeshorn
Berlin
Klinikum der Ruhr Universität , Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Medizinische Klinik III
Bochum
Medizinische Hochschule Hannover, Abteilung für Pneumologie
Hanover
Universitätsklinikum-Schleswig-Holstein, Campus Lübeck, Zentralklinikum, MK III, Studienzentrum Pneumologie-Infektiologie-Onkologie,
Lübeck
Brüderkrankenhaus St. Josef , Innere Abteilung
Paderborn
Diakoniekrankenhaus Rotenburg gGmbH, Lungenklinik Unterstedt , Zentrum für Pneumologie
Rotenburg (Wümme)
Universitätsklinikum Ulm Sektion Pneumologie/Klinik für Innere Medizin II
Ulm
About this study
Official title: Prospective, Doubleblind, Randomized Multicenter Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
The purpose of this study is to prove the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Moxifloxacin, Ampicillin;Amoxicillin
- Keywords
- Ampicillin, Amoxicillin, Moxifloxacin, Community-Acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called Avalox
intravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours)
- 20 ml physiologic saline solution (placebo)(over 30 min) + Moxifloxacin infusion solution(400 mg/250ml) over 60 minutes
- 20 ml physiologic saline solution (placebo) (over 30 min)
- 20 ml physiologic saline solution (placebo) (over 30 min) following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
- 1 capsule Moxifloxacin (400 mg) + 1 capsule Placebo
- 2 capsules Placebo
- 2 capsules Placebo
Total time of the therapy:at least 7 days, but at most 10 days
Ampicillin;AmoxicillinDrug
Also called Ampicillin Ratiopharm, Amoxicillin ratiopharm
intravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours)
- 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) + 250 ml physiologic saline solution (placebo) (over 60 min)
- 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min)
- 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours):
- 2 capsules Amoxicillin (0,5 g)
- 2 capsules Amoxicillin (0,5 g)
- 2 capsules Amoxicillin (0,5 g)
Total time of the therapy: at least 7 days, but at most 10 days
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
| Ampicillin; Amoxicillin | Active comparator | Not described Receives: Drug: Ampicillin;Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of the clinical non inferiority by the cure rate at the treatment of a Pneumonia at the therapy end (round 3: Day 7 to 10) with a standard penicillin in a high dosage
Measured: after at least 7 days, i.e., at the time of round 3 (therapy end)
Secondary outcomes (7)
clinical cure rate
Measured: at round 4 (follow-up: day 28 to 35)
bacteriological effectiveness on patients and seed level
Measured: at round 4 (follow-up: day 28 to 35)
bacteriological sensitivity into-vitro
Measured: at round 4 (follow-up: day 28 to 35)
time up to the drug-switch
Measured: at round 4 (follow-up: day 28 to 35)
time until the dismissal of the patients necessity of the gift of additional antibacterial drug
Measured: at round 4 (follow-up: day 28 to 35)
cost reduction of the antibiotic-therapy and the complete treatment
Measured: at round 4 (follow-up: day 28 to 35)
assessment of the effectiveness by the investigator
Measured: at round 4 (follow-up: day 28 to 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Capnetz Stiftung
- Investigators
- Tobias Welte, Prof., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887276
- Sponsor's protocol ID
- EudraCT number: 2005-000771-18
- Acronym
- PENCAP
- Status last verified
- Jan 2010
- First submitted
- 22 Apr 2009
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Doubleblind, Randomized Multicenter Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT00887276
- Acronym / sponsor ID
- PENCAP / EudraCT number: 2005-000771-18
- Conditions
- Community Acquired Pneumonia
- Keywords
- Ampicillin, Amoxicillin, Moxifloxacin, Community-Acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Capnetz Stiftung
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Apr 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 prove the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Active comparator | Drug: Moxifloxacin |
| Ampicillin; Amoxicillin | Active comparator | Drug: Ampicillin;Amoxicillin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men or women older than 18 years with signed informed consent
- Women in a childbearing age with sufficient conception protection or if necessary negative pregnancy test
- Infiltrates appeared newly in the x-ray thorax
- Breath-conditioned chest pain
- At least two of the following clinical symptoms of a pneumonia:
Key exclusion criteria (9 listed)
- Hospitalization within the last 28 days (except for the last 72 h)
- Participation in another therapy study within the last 4 weeks with studies admission
- intake of an antibiotic longer than 24 hrs within the last 72 hours before studies admission
- Patients in the pregnancy and nursing phase
- Existence of contraindications opposite the examining preparations or other B-Lactam antibiotics or fluorochinolons
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 |
|---|---|---|
| MoxifloxacinAlso: Avaloxintravenous infusion: at least 3 days until to the drug switch (oral use),3 times daily (all 8 hours) 1. 20 ml physiologic saline solution (placebo)(over 30 min) + Moxifloxacin infusion solution(400 mg/250ml) over 60 minutes 2. 20 ml physiologic saline solution (placebo) (over 30 min) 3. 20 ml physiologic saline solution (placebo) (over 30 min) following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours): 1. 1 capsule Moxifloxacin (400 mg) + 1 capsule Placebo 2. 2 capsules Placebo 3. 2 capsules Placebo Total time of the therapy:at least 7 days, but at most 10 days | Drug | Moxifloxacin |
| Ampicillin;AmoxicillinAlso: Ampicillin Ratiopharm, Amoxicillin ratiopharmintravenous infusion:at least 3 days until to the drug switch (oral use), 3 times daily (all 8 hours) 1. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) + 250 ml physiologic saline solution (placebo) (over 60 min) 2. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) 3. 2 g Ampicillin dissolved in 20 ml aqua (i.v. over 30 min) following oral therapy(possible at the earliest day 4): 3 times daily (all 8 hours): 1. 2 capsules Amoxicillin (0,5 g) 2. 2 capsules Amoxicillin (0,5 g) 3. 2 capsules Amoxicillin (0,5 g) Total time of the therapy: at least 7 days, but at most 10 days | Drug | Ampicillin; Amoxicillin |
Primary outcome
Proof of the clinical non inferiority by the cure rate at the treatment of a Pneumonia at the therapy end (round 3: Day 7 to 10) with a standard penicillin in a high dosage
Time frame: after at least 7 days, i.e., at the time of round 3 (therapy end)
7 secondary outcomes
clinical cure rate
Time frame: at round 4 (follow-up: day 28 to 35)
bacteriological effectiveness on patients and seed level
Time frame: at round 4 (follow-up: day 28 to 35)
bacteriological sensitivity into-vitro
Time frame: at round 4 (follow-up: day 28 to 35)
time up to the drug-switch
Time frame: at round 4 (follow-up: day 28 to 35)
time until the dismissal of the patients necessity of the gift of additional antibacterial drug
Time frame: at round 4 (follow-up: day 28 to 35)
cost reduction of the antibiotic-therapy and the complete treatment
Time frame: at round 4 (follow-up: day 28 to 35)
assessment of the effectiveness by the investigator
Time frame: at round 4 (follow-up: day 28 to 35)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Related InfoLink provided by the sponsor.
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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.
Tobias Welte, Prof. principal investigator
Hannover Medical School
8 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 Moxifloxacin and Ampicillin;Amoxicillin in people with Community Acquired Pneumonia, run by University of Ulm at 8 sites in Germany.
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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 was stopped early. Results are not available in the source record.
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?
Proof of the clinical non inferiority by the cure rate at the treatment of a Pneumonia at the therapy end (round 3: Day 7 to 10) with a standard penicillin in a high dosage (time frame: after at least 7 days, i.e., at the time of round 3 (therapy end)). 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 17 Dec 2014.