Community-acquired PneumoniaPhase 4NCT05133752
Oral Nemonoxacin in Treating Elderly Patients With CAP
A Phase 4 study testing Nemonoxacin in people with Community-acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 1 site in Taiwan.
Trial summary
This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Nemonoxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2018to 23 Mar 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
- Clinical diagnosis of CAP
- Evidence of inflammatory exudates or infiltrates on chest X-ray
Who cannot join
- Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia
- History of hypersensitivity to quinolone or fluoroquinolone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia
This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).
- Conditions
- Community-acquired Pneumonia
- Being tested
- Nemonoxacin
- 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.
NemonoxacinDrug
500 mg, oral administration, once daily for 7-10 days.
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin | Experimental | Not described Receives: Drug: Nemonoxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after treatment with oral nemonoxacin once daily for 7-10 days
Measured: From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)
Secondary outcomes (1)
Number of participants with clinical success in the modified intention-to-treat (mITT) population, intention-to-treat (ITT), and clinically evaluable (CE) populations.
Measured: Visit 3 (within 24 hr after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start11 Sep 2018
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133752
- Sponsor's protocol ID
- TG-873870-05
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05133752
- Acronym / sponsor ID
- TG-873870-05
- Conditions
- Community-acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 24 Nov 2021 (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 was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin | Experimental | Drug: Nemonoxacin |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years
- Clinical diagnosis of CAP
- Evidence of inflammatory exudates or infiltrates on chest X-ray
Key exclusion criteria (2 listed)
- Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia
- History of hypersensitivity to quinolone or fluoroquinolone
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 |
|---|---|---|
| Nemonoxacin500 mg, oral administration, once daily for 7-10 days. | Drug | Nemonoxacin |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after treatment with oral nemonoxacin once daily for 7-10 days
Time frame: From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)
1 secondary outcome
Number of participants with clinical success in the modified intention-to-treat (mITT) population, intention-to-treat (ITT), and clinically evaluable (CE) populations.
Time frame: Visit 3 (within 24 hr after last dose)
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 24 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nemonoxacin in people with Community-acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 1 site in Taiwan.
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 3 inclusion and 2 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 24 Nov 2021. 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 Taiwan. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after treatment with oral nemonoxacin once daily for 7-10 days (time frame: From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)). 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 24 Nov 2021.