Hospital InfectionsPhase 4NCT05575427
Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections
A Phase 4 study testing Minocycline and Levofloxacin or Cotrimoxazole in people with Hospital Infections, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of the study is to evaluate the efficacy of minocycline for treatment Stenotrophomonas maltophilia infection. The hypothesis of study is the combination therapy with minocycline would be better than the monotherapy for treatment Stenotrophomonas maltophilia infection. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hospital Infections
- What is being tested?
- Minocycline and Levofloxacin or Cotrimoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- 24 Nov 2022to 1 Nov 2024
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The infection caused by Stenotrophomonas maltophilia
- The duration of treatment approximately between 7-28 days
- The patients can take minocycline capsule via oral or nasogastric tube feeding.
- The patients are anticipated to live more than 48 hrs after participation.
- In case of an antibiotic drug administration for treatment Stenotrophomonas maltophilia beforehand, it should not exceed 48 hrs.
- All of participants should be willing to join this project.
Who cannot join
- Pregnancy and lactation
- The patients with active hepatitis
- The patients with history of minocycline allergy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Adhiratha Boonyasiri, MD, +6624192688, adhiratha.bon@mahidol.ac.th
Adhiratha Boonyasiri, MD
About this study
The objective of the study is to evaluate the efficacy of minocycline for treatment Stenotrophomonas maltophilia infection. The hypothesis of study is the combination therapy with minocycline would be better than the monotherapy for treatment Stenotrophomonas maltophilia infection.
Read the detailed description
- Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment.
- After patient or their relatives are appreciated to join this project, patients will be randomly allocated to either levofloxacin or cotrimoxazole plus placebo (monotherapy plus placebo) or levofloxacin or cotrimoxazole plus minocycline (combination therapy).
- Duration of treatment is determined by site and severity of infection, approximately 7-28 days.
- Sample size calculation, by two independent proportions formula, the investigators estimate the mortality rate about 54 % in monotherapy group and mortality rate about 27 % in combination therapy with minocycline group, with 2-sided 95% Confidence interval; therefore,51 persons are needed each group.
- The investigators estimate gather data about 112 persons. (56 participants with monotherapy and 56 participants with combination therapy (minocycline plus another antibiotic drug from intervention trial))
- The categorical variables are reported as frequencies and percentages, while continuous variables are reported as means ± standard deviations for normally distributed data and median ± range for non-normally distributed data. The data collected from patients are compared using Chi-square tests or Fisher's exact tests for categorical variables and using t-tests or Mann-Whitney U-tests for continuous variables.
- During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
- Conditions
- Hospital Infections
- Being tested
- Minocycline, Levofloxacin or Cotrimoxazole, Placebo
- Keywords
- Minocycline, Stenotrophomonas maltophilia
- Medical subject headings
- Cross Infection, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Mino
The patients will receive minocycline oral between 7-28 days
Levofloxacin or CotrimoxazoleDrug
Also called Cravit or Bactrim
The patients will receive levofloxacin or cotrimoxazole oral between 7-28 days
PlaceboDrug
Capsule without active compound
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with minocycline | Experimental | Minocycline oral 50 mg per capsule
4 capsules oral stat then 2 capsules oral every 12 hours
duration 7-28 days Receives: Drug: Minocycline; Drug: Levofloxacin or Cotrimoxazole |
| Monotherapy plus placebo | Active comparator | Patients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo Receives: Drug: Levofloxacin or Cotrimoxazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rate of S. maltophilia infected patients receiving treatment at day 28
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (2)
microbiological clearance
we perform culture and staining to assess bacterial clearance after apply the study drug
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
adverse drug reactions
we assess adverse drug reactions in 2 aspects; nephrotoxicity and hepatotoxicity
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start24 Nov 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospital InfectionsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 4 Randomized, Double blind, Placebo Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adhiratha Boonyasiri, MD, Principal investigator, Department of research, Faculty of Medicine Siriraj hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575427
- Sponsor's protocol ID
- SI-CEU-01-2022
- Status last verified
- Jan 2023
- First submitted
- 7 Oct 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Junco SJ, Bowman MC, Turner RB. Clinical outcomes of Stenotrophomonas maltophilia infection treated with trimethoprim/sulfamethoxazole, minocycline, or fluoroquinolone monotherapy. Int J Antimicrob Agents. 2021 Aug;58(2):106367. doi: 10.1016/j.ijantimicag.2021.106367. Epub 2021 May 28.
PubMed 34058337Insuwanno W, Kiratisin P, Jitmuang A. Stenotrophomonas maltophilia Infections: Clinical Characteristics and Factors Associated with Mortality of Hospitalized Patients. Infect Drug Resist. 2020 May 28;13:1559-1566. doi: 10.2147/IDR.S253949. eCollection 2020.
PubMed 32547125
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections
- ClinicalTrials.gov ID
- NCT05575427
- Acronym / sponsor ID
- SI-CEU-01-2022
- Conditions
- Hospital Infections
- Keywords
- Minocycline, Stenotrophomonas maltophilia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 12 Oct 2022 (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.
The objective of the study is to evaluate the efficacy of minocycline for treatment Stenotrophomonas maltophilia infection. The hypothesis of study is the combination therapy with minocycline would be better than the monotherapy for treatment Stenotrophomonas maltophilia infection.
Detailed description
- Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment.
- After patient or their relatives are appreciated to join this project, patients will be randomly allocated to either levofloxacin or cotrimoxazole plus placebo (monotherapy plus placebo) or levofloxacin or cotrimoxazole plus minocycline (combination therapy).
- Duration of treatment is determined by site and severity of infection, approximately 7-28 days.
- Sample size calculation, by two independent proportions formula, the investigators estimate the mortality rate about 54 % in monotherapy group and mortality rate about 27 % in combination therapy with minocycline group, with 2-sided 95% Confidence interval; therefore,51 persons are needed each group.
- The investigators estimate gather data about 112 persons. (56 participants with monotherapy and 56 participants with combination therapy (minocycline plus another antibiotic drug from intervention trial))
- The categorical variables are reported as frequencies and percentages, while continuous variables are reported as means ± standard deviations for normally distributed data and median ± range for non-normally distributed data. The data collected from patients are compared using Chi-square tests or Fisher's exact tests for categorical variables and using t-tests or Mann-Whitney U-tests for continuous variables.
- During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Phase 4 Randomized, Double blind, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Combination therapy with minocycline | Experimental | Drug: Minocycline, Drug: Levofloxacin or CotrimoxazoleMinocycline oral 50 mg per capsule 4 capsules oral stat then 2 capsules oral every 12 hours duration 7-28 days |
| Monotherapy plus placebo | Active comparator | Drug: Levofloxacin or Cotrimoxazole, Drug: PlaceboPatients were treated Stenotrophomonas maltophilia infection with standard monotherapy either levofloxacin or Trimethoprim/sulfamethoxazole plus placebo |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The infection caused by Stenotrophomonas maltophilia
- The duration of treatment approximately between 7-28 days
- The patients can take minocycline capsule via oral or nasogastric tube feeding.
- The patients are anticipated to live more than 48 hrs after participation.
- In case of an antibiotic drug administration for treatment Stenotrophomonas maltophilia beforehand, it should not exceed 48 hrs.
Key exclusion criteria (3 listed)
- Pregnancy and lactation
- The patients with active hepatitis
- The patients with history of minocycline allergy
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 |
|---|---|---|
| MinocyclineAlso: MinoThe patients will receive minocycline oral between 7-28 days | Drug | Combination therapy with minocycline |
| Levofloxacin or CotrimoxazoleAlso: Cravit or BactrimThe patients will receive levofloxacin or cotrimoxazole oral between 7-28 days | Drug | Combination therapy with minocycline, Monotherapy plus placebo |
| PlaceboCapsule without active compound | Drug | Monotherapy plus placebo |
Primary outcome
mortality rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
mortality rate of S. maltophilia infected patients receiving treatment at day 28
2 secondary outcomes
microbiological clearance
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
adverse drug reactions
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 34058337Junco SJ, Bowman MC, Turner RB. Clinical outcomes of Stenotrophomonas maltophilia infection treated with trimethoprim/sulfamethoxazole, minocycline, or fluoroquinolone monotherapy. Int J Antimicrob Agents. 2021 Aug;58(2):106367. doi: 10.1016/j.ijantimicag.2021.106367. Epub 2021 May 28.
- Background: PubMed 32547125Insuwanno W, Kiratisin P, Jitmuang A. Stenotrophomonas maltophilia Infections: Clinical Characteristics and Factors Associated with Mortality of Hospitalized Patients. Infect Drug Resist. 2020 May 28;13:1559-1566. doi: 10.2147/IDR.S253949. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Hospital Infections
Not yet recruiting
HAIQU (Hospital AIr QUality)
Acute Respiratory Tract Infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
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.
Adhiratha Boonyasiri, MD principal investigator
Department of research, Faculty of Medicine Siriraj hospital, Mahidol University
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 Minocycline and Levofloxacin or Cotrimoxazole in people with Hospital Infections, run by Mahidol University at 1 site in Thailand.
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 3 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 10 Jan 2023. 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 Thailand. 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 Tuvanont Pongdumbun, MD (+66886822000, tuvanontp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks). 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 NCT05575427, which also lists 2 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 10 Jan 2023.