Community-acquired Pneumonia (CAP)Phase 3PENIPNEUMONCT03208361
Efficacy of High Doses Penicillin V Versus High Doses Amoxicillin in the Treatment of Non-severe Pneumonia.
A Phase 3 study testing Penicillin V and Amoxicillin in people with Community-acquired Pneumonia (CAP), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
This study aims to evaluate wether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Community-acquired Pneumonia (CAP)
- What is being tested?
- Penicillin V and Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2013to 21 Apr 2016
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years to 75 years (inclusive).
- Signs and symptoms of lower respiratory tract infection.
- Radiological confirmation of the diagnosis of pneumonia or not radiological confirmation but the patient has the following symptoms: high fever (> 38.5 ° C), cough and purulent sputum and auscultation of crackles in a pulmonary focus, the researcher undertakes to confirm after inclusion pneumonia with mandatory radiological study.
- Signature of informed consent.
Who cannot join
- Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at the discretion of the investigator
- Respiratory rate> 30 breaths / minute
- Heart rate> 125 beats / minute
- Systolic blood pressure <90 mm ??Hg or diastolic BP <60 mm Hg
- Hypersensitivity to beta-Lactamics
- O2 saturation <92%
Show all 20Show fewer
- Axillary temperature> 40 ° C
- bronchial Asthma
- Pregnancy or lactation
- Significant comorbidities: renal failure, liver cirrhosis, heart failure, chronic obstructive pulmonary disease, ischemic heart disease diagnosed less than 6 months, stroke diagnosed less than 6 months ago and / or type 1 diabetes mellitus
- Significant alteration in chest radiography: alveolar infiltrates in more than one lobe or bilateral pleural effusion or pulmonary cavitation
- Problems to meet the treatment at home: sociopathy or psychiatric problems, drug and alcohol addiction, or, an unsuitable family environment
- Lack of tolerance to oral therapy: presence of nausea and vomiting, gastrectomy, post-surgery or frank diarrhea
- Immunosuppression: chronic HIV infection, transplant, neutropenic, or, patients receiving immunosuppressive therapy
- active malignancy
- terminal disease
- Hospitalization in the last month
- Taking any systemic antibiotic in the previous three days or a full use of oral antibiotics prior to inclusion in the previous two weeks (use of urinary antiseptics is not a reason for exclusion).
- Difficulty to attend follow-up visits
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High Doses of Oral Penicillin V Versus High Doses of Oral Amoxicillin in the Treatment of Non-severe Community-acquired Pneumonia in Adults
This study aims to evaluate wether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP).
Read the detailed description
Phase III parallel-group, randomised, double blind clinical trial, performed in 31 primary healthcare centres in Spain.
The use of narrow-spectrum antibiotics is needed because of the dearth of new antimicrobials and the link observed between the consumption of broad-spectrum antibiotics and the emergence and spread of antibacterial resistance.
Objective: The aim of the present trial was to determine whether high-dose penicillin V was as effective as high-dose amoxicillin for the treatment of uncomplicated CAP in a Mediterranean adult population.
Subjects: Patients between 18-75 years with lower respiratory tract infection and radiologically confirmed diagnosis of pneumonia.
Primary outcome: Clinical resolution at day 14
Visit Schedule: Initiation visit, day 3 phone call, day 14 presential visit, day 30 presential visit.
Quality: The study will be conducted in accordance with the principles of the Declaration of Helsinki, ICH Guidelines for GCP and in full conformity with relevant regulations. The study has been approved by the Ethical Committee of Investigation in Primary Care (Fundació d'Investigació en Atenció Primària) and by the Agencia Española del Medicamento y Productos Sanitarios. The study data was fully monitored by speciallized personnel.
Sample size: The objective of the study is to demonstrate that penicillin V is not inferior to amoxicillin. Considering a success rate of 85% for the group treated with amoxicillin [1,2]. A total of 105 patients will be required in each treatment group (total of 210) to detect a non-inferiority margin of 15% between the two treatments with a minimum power of 80% considering an alpha error of 2.5% for a unilateral hypothesis and maximum possible losses of 15%.
Statistical analyses:The intention-to-treat (ITT) population included all randomized patients receiving at least one dose of study drug and the per-protocol (PP) population included patients who received no systemic antimicrobial agents other than the study drug for at least three days in the case of clinical failure or ≥80% of study medication in the case of cure, with adequate assessment of compliance and absence of major protocol violations.
To evaluate the comparability of the groups the two groups will be analysed with variables expressed as means and standard deviations for the case of quantitative variables and with proportions in the case of qualitative variables. The variable of the principle result, clinical cure, will be expressed as percentages and the comparison of percentages in the two treatment groups will be analysed using the Chi-square test. Logistic regression will be performed for the analysis of the predictive factors of cure or not, with calculation of the odds ratio for each of the variables analysed and multiadjustment for each of the factors of the study with confidence intervals of 95%. Variables with a p<0.20 on bivariant analysis will be included in the analysis. A p value < 0.05 will be considered statistically significant.
The protocol of the study has been published (3)
- Conditions
- Community-acquired Pneumonia (CAP)
- Being tested
- Penicillin V, Amoxicillin
- 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.
Penicillin VDrug
AmoxicillinDrug
| Study group | Role | What they receive |
|---|---|---|
| Penicillin V | Experimental | Penicillin V, 1600000 IU every 8h during 10 days. Receives: Drug: Penicillin V |
| Amoxicillin | Active comparator | Amoxicillin, 1 g every 8h during 10 days. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disappearance of fever
Disappearance of fever (included in the general definition of Clinical Cure)
Measured: 14 days after inclusion
Disappearance or improvement of cough
Disappearance or improvement of cough (included in the general definition of Clinical Cure)
Measured: 14 days after inclusion
Improvement of general condition
Improvement of general condition (included in the general definition of Clinical Cure)
Measured: 14 days after inclusion
Disappearance or reduction of auscultation of crackles
Disappearance or reduction of auscultation of crackles (included in the general definition of Clinical Cure)
Measured: 14 days after inclusion
No other antimicrobial treatment necessary
No other antimicrobial treatment necessary (included in the general definition of Clinical Cure
Measured: 14 days after inclusion
Secondary outcomes (9)
Disappearance of fever
Disappearance of fever (included in the general definition of Clinical Cure)
Measured: 30 days after inclusion
disappearance or improvement of cough
disappearance or improvement of cough (included in the general definition of clinical cure)
Measured: 30 days after inclusion
improvement of general condition
improvement of general condition (included in the general definition of clinical cure)
Measured: 30 days after inclusion
disappearance or reduction of auscultation of crackles
disappearance or reduction of auscultation of crackles (included in the general definition of clinical cure)
Measured: 30 days after inclusion
No other antimicrobial treatment necessary
No other antimicrobial treatment necessary (included in the general definition of Clinical cure)
Measured: 30 days after inclusion
Total Clinical Resolution
Total resolution of acute signs and symptoms, so no other antimicrobial treatment is needed.
Measured: 14 days after inclusion
Total Clinical Resolution
Total resolution of acute signs and symptoms, so no other antimicrobial treatment is needed.
Measured: 30 days after inclusion
Radiological resolution
Partial or complete resolution of the pulmonar condensation Chest X-Ray
Measured: 30 days after inclusion
Adverse Events
Presence of adverse events during all the study period.
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start5 Nov 2013
- Primary completion29 Mar 2016
- Study completion21 Apr 2016
Why it stopped: Lack of financial support to continue with the study recruitment. Independent study financially supported by a national grant with a 4.5 years duration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Community-acquired Pneumonia (CAP)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Penicillin V (phenoxymethylpenicillin) Arm 2: Amoxicillin (control)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Car Llor Vilà, MD, PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208361
- Sponsor's protocol ID
- IJG-PEN-2012
- Other IDs
- 2012-003511-63
- Acronym
- PENIPNEUMO
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aubier M, Verster R, Regamey C, Geslin P, Vercken JB. Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Sparfloxacin European Study Group. Clin Infect Dis. 1998 Jun;26(6):1312-20. doi: 10.1086/516366.
PubMed 9636854Petitpretz P, Arvis P, Marel M, Moita J, Urueta J; CAP5 Moxifloxacin Study Group. Oral moxifloxacin vs high-dosage amoxicillin in the treatment of mild-to-moderate, community-acquired, suspected pneumococcal pneumonia in adults. Chest. 2001 Jan;119(1):185-95. doi: 10.1378/chest.119.1.185.
PubMed 11157603Llor C, Arranz J, Morros R, Garcia-Sangenis A, Pera H, Llobera J, Guillen-Sola M, Carandell E, Ortega J, Hernandez S, Miravitlles M. Efficacy of high doses of oral penicillin versus amoxicillin in the treatment of adults with non-severe pneumonia attended in the community: study protocol for a randomised controlled trial. BMC Fam Pract. 2013 Apr 17;14:50. doi: 10.1186/1471-2296-14-50.
PubMed 23594463
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Doses of Oral Penicillin V Versus High Doses of Oral Amoxicillin in the Treatment of Non-severe Community-acquired Pneumonia in Adults
- ClinicalTrials.gov ID
- NCT03208361
- Acronym / sponsor ID
- PENIPNEUMO / IJG-PEN-2012
- Conditions
- Community-acquired Pneumonia (CAP)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financial support to continue with the study recruitment. Independent study financially supported by a national grant with a 4.5 years duration.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 29 Mar 2016 (actual)
- Study completion
- 21 Apr 2016 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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 aims to evaluate wether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-sever community-acquired pneumonia (CAP).
Detailed description
Phase III parallel-group, randomised, double blind clinical trial, performed in 31 primary healthcare centres in Spain.
The use of narrow-spectrum antibiotics is needed because of the dearth of new antimicrobials and the link observed between the consumption of broad-spectrum antibiotics and the emergence and spread of antibacterial resistance.
Objective: The aim of the present trial was to determine whether high-dose penicillin V was as effective as high-dose amoxicillin for the treatment of uncomplicated CAP in a Mediterranean adult population.
Subjects: Patients between 18-75 years with lower respiratory tract infection and radiologically confirmed diagnosis of pneumonia.
Primary outcome: Clinical resolution at day 14
Visit Schedule: Initiation visit, day 3 phone call, day 14 presential visit, day 30 presential visit.
Quality: The study will be conducted in accordance with the principles of the Declaration of Helsinki, ICH Guidelines for GCP and in full conformity with relevant regulations. The study has been approved by the Ethical Committee of Investigation in Primary Care (Fundació d'Investigació en Atenció Primària) and by the Agencia Española del Medicamento y Productos Sanitarios. The study data was fully monitored by speciallized personnel.
Sample size: The objective of the study is to demonstrate that penicillin V is not inferior to amoxicillin. Considering a success rate of 85% for the group treated with amoxicillin [1,2]. A total of 105 patients will be required in each treatment group (total of 210) to detect a non-inferiority margin of 15% between the two treatments with a minimum power of 80% considering an alpha error of 2.5% for a unilateral hypothesis and maximum possible losses of 15%.
Statistical analyses:The intention-to-treat (ITT) population included all randomized patients receiving at least one dose of study drug and the per-protocol (PP) population included patients who received no systemic antimicrobial agents other than the study drug for at least three days in the case of clinical failure or ≥80% of study medication in the case of cure, with adequate assessment of compliance and absence of major protocol violations.
To evaluate the comparability of the groups the two groups will be analysed with variables expressed as means and standard deviations for the case of quantitative variables and with proportions in the case of qualitative variables. The variable of the principle result, clinical cure, will be expressed as percentages and the comparison of percentages in the two treatment groups will be analysed using the Chi-square test. Logistic regression will be performed for the analysis of the predictive factors of cure or not, with calculation of the odds ratio for each of the variables analysed and multiadjustment for each of the factors of the study with confidence intervals of 95%. Variables with a p<0.20 on bivariant analysis will be included in the analysis. A p value < 0.05 will be considered statistically significant.
The protocol of the study has been published (3)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: Penicillin V (phenoxymethylpenicillin) Arm 2: Amoxicillin (control)
| Arm | Type | Receives |
|---|---|---|
| Penicillin V | Experimental | Drug: Penicillin VPenicillin V, 1600000 IU every 8h during 10 days. |
| Amoxicillin | Active comparator | Drug: AmoxicillinAmoxicillin, 1 g every 8h during 10 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years to 75 years (inclusive).
- Signs and symptoms of lower respiratory tract infection.
- Radiological confirmation of the diagnosis of pneumonia or not radiological confirmation but the patient has the following symptoms: high fever (> 38.5 ° C), cough and purulent sputum and auscultation of crackles in a pulmonary focus, the researcher undertakes to confirm after inclusion pneumonia with mandatory radiological study.
- Signature of informed consent.
Key exclusion criteria (20 listed)
- Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at the discretion of the investigator
- Respiratory rate> 30 breaths / minute
- Heart rate> 125 beats / minute
- Systolic blood pressure <90 mm ??Hg or diastolic BP <60 mm Hg
- Hypersensitivity to beta-Lactamics
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 |
|---|---|---|
| Penicillin V | Drug | Penicillin V |
| Amoxicillin | Drug | Amoxicillin |
Primary outcome
Disappearance of fever
Time frame: 14 days after inclusion
Disappearance of fever (included in the general definition of Clinical Cure)
Disappearance or improvement of cough
Time frame: 14 days after inclusion
Disappearance or improvement of cough (included in the general definition of Clinical Cure)
Improvement of general condition
Time frame: 14 days after inclusion
Improvement of general condition (included in the general definition of Clinical Cure)
Disappearance or reduction of auscultation of crackles
Time frame: 14 days after inclusion
Disappearance or reduction of auscultation of crackles (included in the general definition of Clinical Cure)
No other antimicrobial treatment necessary
Time frame: 14 days after inclusion
No other antimicrobial treatment necessary (included in the general definition of Clinical Cure
9 secondary outcomes
Disappearance of fever
Time frame: 30 days after inclusion
disappearance or improvement of cough
Time frame: 30 days after inclusion
improvement of general condition
Time frame: 30 days after inclusion
disappearance or reduction of auscultation of crackles
Time frame: 30 days after inclusion
No other antimicrobial treatment necessary
Time frame: 30 days after inclusion
Total Clinical Resolution
Time frame: 14 days after inclusion
Total Clinical Resolution
Time frame: 30 days after inclusion
Radiological resolution
Time frame: 30 days after inclusion
Adverse Events
Time frame: 1-30 days
Results and safety
The study was stopped early (reason given: Lack of financial support to continue with the study recruitment. Independent study financially supported by a national grant with a 4.5 years duration.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Background: PubMed 9636854Aubier M, Verster R, Regamey C, Geslin P, Vercken JB. Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Sparfloxacin European Study Group. Clin Infect Dis. 1998 Jun;26(6):1312-20. doi: 10.1086/516366.
- Background: PubMed 11157603Petitpretz P, Arvis P, Marel M, Moita J, Urueta J; CAP5 Moxifloxacin Study Group. Oral moxifloxacin vs high-dosage amoxicillin in the treatment of mild-to-moderate, community-acquired, suspected pneumococcal pneumonia in adults. Chest. 2001 Jan;119(1):185-95. doi: 10.1378/chest.119.1.185.
- Background: PubMed 23594463Llor C, Arranz J, Morros R, Garcia-Sangenis A, Pera H, Llobera J, Guillen-Sola M, Carandell E, Ortega J, Hernandez S, Miravitlles M. Efficacy of high doses of oral penicillin versus amoxicillin in the treatment of adults with non-severe pneumonia attended in the community: study protocol for a randomised controlled trial. BMC Fam Pract. 2013 Apr 17;14:50. doi: 10.1186/1471-2296-14-50.
- Individual participant dataSharing planned: Undecided
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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.
Car Llor Vilà, MD, PhD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Penicillin V and Amoxicillin in people with Community-acquired Pneumonia (CAP), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 20 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (reason given: Lack of financial support to continue with the study recruitment. Independent study financially supported by a national grant with a 4.5 years duration.). 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?
Disappearance of fever (time frame: 14 days after inclusion). The study lists 5 primary outcomes in all. 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 NCT03208361, which also lists 3 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 5 Jul 2017.