Community-acquired PneumoniaPhase 42017-001406-15NCT03609099
Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
A Phase 4 study testing Moxifloxacin in people with Community-acquired Pneumonia, run by David Garcia Cinca at 5 sites in Spain.
Trial summary
Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 5 sitesSpain
- Study dates
- 15 Feb 2019to 15 May 2021
- 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
- Patients of both sexes older than 18 years
- Hospitalized patients diagnosed with CAP: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (> 38 ° C), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
- That they present a PSI score class IV or V.
- Patients who have received adequate antibiotic treatment according to clinical guidelines (SEPAR, ATS) ((1,8,19)) from the first hour of admission to the emergency room.
- Patients who reach clinical stability: temperature ≤37.2 ºC, heart rate ≤100 beats / min, respiratory rate ≤24 breaths / min, systolic blood pressure> 90 mmHg; oxygen saturation> 90%; or oxygen blood pressure> 60 mmHg (15) before the fourth day.
- Signature of informed consent.
Who cannot join
- Immunosuppression: Co infection with HIV and presence of AIDS, treatment with neutropenic effect or have received immunosuppressive treatment for any reason. Patients that are in chronic use of corticosteroids as prednisone or its equivalent with > 10 mg / day for 14 days.
- Patients hospitalized in the previous 14 days.
- Patients with pleural effusion
- Suspected multiresistant germs of any cause.
- Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
- Pregnancy or lactation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Miquel Ferrer, MD, +34.227.54.00
Miquel Ferrer, MD
- Recruiting
Hospital Galdakao-Usansolo
Galdakao, Bizkaia, 48960
Pedro España, MD, +34.944.00.70.00
Pedro España, MD
- Recruiting
Hospital de Mataró
Mataró, Barcelona, 08304
Jordi Almirall, MD, +34.93.741.77.00
Jordi Almirall, MD
- Recruiting
Hospital Universitario Virgen de Valme
Seville, 41001
Inmaculada Alfageme, MD, +34.902.50.50.61
Inmaculada Alfageme, MD
- Recruiting
Hospital Universitario La Fe
Valencia, Valencia, 46026
Rosario Menéndez, MD, +34.961.24.40.00
Rosario Menéndez, MD
About this study
Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Moxifloxacin, Placebo
- 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 Active treatment
400 mg / day once a day oral treatment during 3 days.
PlaceboDrug
once a day oral treatment during 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Active comparator | Active treatment to patients treated during the 5 previous days. Receives: Drug: Moxifloxacin |
| Placebo | Experimental | Placebo treatment to patients treated during the 5 previous days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment failure
Treatment failure is defined as the appearance of any of the following manifestations: death from any cause, hospital readmission for any cause or restart of antibiotic treatment for any reason.
Measured: during the 30 days after the day of hospital admission
Secondary outcomes (4)
Length of hospital stay
Measured: up to 2 years
Antibiotic-free days
Antibiotic-free days are defined as the number of days alive and free of antibiotics
Measured: Up to 28 days
Proportion of adverse events
Measured: Up to 28 days
Proportion of serious adverse events
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start15 Feb 2019
- Primary completion15 Nov 2020 (estimated)
- Study completion15 May 2021 (estimated)
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Garcia Cinca
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica, Miquel Ferrer - Investigator Coordinator
- Responsible party
- Sponsor-investigator, David Garcia Cinca, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609099
- Sponsor's protocol ID
- NAC-ATB
- Acronym
- 2017-001406-15
- Status last verified
- Dec 2019
- First submitted
- 23 Jul 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
- ClinicalTrials.gov ID
- NCT03609099
- Acronym / sponsor ID
- 2017-001406-15 / NAC-ATB
- Conditions
- Community-acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- David Garcia CincaUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica, Miquel Ferrer - Investigator Coordinator
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 1 Aug 2018 (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.
Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Active comparator | Drug: MoxifloxacinActive treatment to patients treated during the 5 previous days. |
| Placebo | Experimental | Drug: PlaceboPlacebo treatment to patients treated during the 5 previous days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sexes older than 18 years
- Hospitalized patients diagnosed with CAP: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (> 38 ° C), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
- That they present a PSI score class IV or V.
- Patients who have received adequate antibiotic treatment according to clinical guidelines (SEPAR, ATS) ((1,8,19)) from the first hour of admission to the emergency room.
- Patients who reach clinical stability: temperature ≤37.2 ºC, heart rate ≤100 beats / min, respiratory rate ≤24 breaths / min, systolic blood pressure> 90 mmHg; oxygen saturation> 90%; or oxygen blood pressure> 60 mmHg (15) before the fourth day.
Key exclusion criteria (6 listed)
- Immunosuppression: Co infection with HIV and presence of AIDS, treatment with neutropenic effect or have received immunosuppressive treatment for any reason. Patients that are in chronic use of corticosteroids as prednisone or its equivalent with > 10 mg / day for 14 days.
- Patients hospitalized in the previous 14 days.
- Patients with pleural effusion
- Suspected multiresistant germs of any cause.
- Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
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: Active treatment400 mg / day once a day oral treatment during 3 days. | Drug | Moxifloxacin |
| Placeboonce a day oral treatment during 3 days. | Drug | Placebo |
Primary outcome
Rate of treatment failure
Time frame: during the 30 days after the day of hospital admission
Treatment failure is defined as the appearance of any of the following manifestations: death from any cause, hospital readmission for any cause or restart of antibiotic treatment for any reason.
4 secondary outcomes
Length of hospital stay
Time frame: up to 2 years
Antibiotic-free days
Time frame: Up to 28 days
Proportion of adverse events
Time frame: Up to 28 days
Proportion of serious adverse events
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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Local Antibiotic Delivery for Community Acquired Pneumonia
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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.
5 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 in people with Community-acquired Pneumonia, run by David Garcia Cinca at 5 sites 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Ceccato, MSD (+34.93.227.54.00, aceccato@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment failure (time frame: during the 30 days after the day of hospital admission). 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 5 Dec 2019.