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Tuberculosis, PulmonaryPhase 3NCT05454345

Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment

A Phase 3 study testing Sitafloxacin, SMZ/TMP and Rifampin in people with Tuberculosis, Pulmonary, run by First Affiliated Hospital of Zhejiang University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a clinical trial conducted to determine whether the sitafloxacin-containing three-month regimens are as effective as the standard six-month regimen and the four-month rifapentine and moxifloxacin regimen (substitution of rifapentine for rifampin and moxifloxacin for ethambutol) for treatment of pulmonary… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Tuberculosis, Pulmonary
What is being tested?
Sitafloxacin, SMZ/TMP and Rifampin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
620 participants
Where
No sites listed yet
Study dates
1 Oct 2022to 30 Jun 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years to 70.
  • At least one sputum specimen is positive for acid-fast bacilli or positive results of sputum culture on smear microscopy(species identification as M. tuberculosis) or at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing.
  • Phenotypic drug susceptibility testing indicates the patient's isolate is susceptible to rifampin, isoniazid, pyrazinamide, ethambutol, rifapentine, moxifloxacin, and Sitafloxacin.
  • Patients have written informed consent.

Who cannot join

  • Extra-pulmonary or Disseminated TB.
  • HIV-positive individuals, steroid-dependent and those on steroid treatment.
  • Autoimmune diseases, severe hepatic or renal dysfunction, psychosis, hematological malignancies, cancer, diabetes individuals.
  • Known allergy to one or more of the study drugs.
  • Women who are currently pregnant or breast-feeding.
  • Patients who received any investigational drug in the past three months.
Show all 9Show fewer
  • The patients refused treatment with medications
  • Mycobacterium tuberculosis/nontuberculous mycobacterium co-infection.
  • In the investigator's judgment, other medical conditions that are not in the individual's best interest to participate.

About this study

Official title: A Randomized Controlled Non-Inferiority Study for Shortening Tuberculosis Treatment With Sitafloxacin-Containing Regimens

This study is a clinical trial conducted to determine whether the sitafloxacin-containing three-month regimens are as effective as the standard six-month regimen and the four-month rifapentine and moxifloxacin regimen (substitution of rifapentine for rifampin and moxifloxacin for ethambutol) for treatment of pulmonary tuberculosis. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide, followed by four months of isoniazid and rifampin. The four-month regimen consists of two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid rifapentine and moxifloxacin. The new three-month tuberculosis treatment regimens are six weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide, followed by seven weeks of isoniazid, rifapentine, and Sitafloxacin, or 13 weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide. The primary research question is to evaluate the efficacy and safety of the 3 month Sitafloxacin-containing regimen, and to determine if it can shorten the treatment of drug-susceptible pulmonary tuberculosis while achieving non-inferiority in treatment success with the current 6 month and 4 month treatment regimens. Safety, side effects of Sitafloxacin for participants in the clinical trial are also assessed. Rates of cure, treatment success, recurrence, and cure (cure without recurrence) are determined for subgroup analysis in the standard six-month regimen group, the four-month regimen group, and two three-month regimen groups.

Read the detailed description
  1. TB disease-free survival at 13 weeks after study treatment assignment among participants in the three-month regimen group 1 and 2, the four-month regimen group, and the standard six-month regimen. The patients are AFB sputum smear negative or culture negative for M. tuberculosis, two assays are performed (each test is separated by at least seven days), eliminating the M. tuberculosis load from a pulmonary infection.
  2. Persons with positive culture results for M. tuberculosis or smear-positive sputum(spoligotyping isolates genetically identified as M. tuberculosis).
  3. Data collected pre-study included written informed consent; patients assessed for eligibility; height and weight; clinical symptoms of TB; adjunctive therapy; adverse drug reaction; blood and urine routine; liver and kidney function; acid-fast staining; single M. tuberculosis strain isolated from one patient with TB; GeneXpert MTB/RIF; chest CT scans
  4. Clinical symptoms of TB: cough, expectoration, hemoptysis, chest pain, fever, shortness of breath, weak.
  5. All patients should review for Xpert MTB/RIF assay in the second week.
  6. During treatment, clinical symptoms of TB and body weights takes weekly; blood and urine routine in weeks 1,2,4,8,13; Sputum smears and culture were routinely in weeks 1,2,4,8,13, and months 6 and 12. TB Disease-free Survival at six or twelve months after study treatment assignment as the secondary outcome measures.
  7. TB patients were identified through bacteriological confirmation (smear-positive and/or culture-positive).
  8. Pulmonary TB patients showed manifestation of tuberculosis by chest CT scans or X-ray.
  9. Adverse events of the treatment: neurological diseases, blood system diseases; diseases of the circulatory system; respiratory diseases; digestive diseases; extra-pulmonary TB; diabetes; arthralgia; mental disorders; hemoptysis and pneumothorax; pulmonary embolism; skin rash.
  10. Management of a participant with a positive sputum culture for M. tuberculosis at or after week 13: A second sputum sample was collected on the following day for a second culture. If M. tuberculosis is isolated in culture, drug susceptibility testing should be performed on one isolate. Patients will re-evaluate symptoms and chest CT scans; sputum was performed in triplicates and repeated for validation. These patients could restart the standard six-month regimen at any time.
  11. Patients follow up one week after the completion of treatment and 6,12,18 months after treatment is over. Patients undergo regular follow-up with sputum smear tests or imaging studies. Patients with positive TB symptom screen or suspected TB patients based on imaging tests are recommended with research staff.
Being tested
Sitafloxacin, SMZ/TMP, Rifampin, Pyrazinamide, Rifapentine
Medical subject headings
Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitafloxacinDrug

    In our Intervention group, sitafloxacin replace the ethambutol, 200mg/d

  • SMZ/TMPDrug

    In our The three-month Rifapentine\&Isoniazid\&Pyrazinamide\&Sitafloxacin\&SMZ/TMP-containing regimen, Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ/TMP and Sitafloxacin, SMZ 80mg/kg/d, TMP16mg/kg/d

  • RifampinDrug

    Rifampin is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, Rifampin 600mg (8-12mg/kg/d)

  • PyrazinamideDrug

    Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg/kg/d)

  • RifapentineDrug

    In our Intervention group, rifapentine replace rifampin, 600mg/d

  • IsoniazidDrug

    Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)

  • EthambutolDrug

    Ethambutol is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 1200mg (15-25mg/kg/d)

  • MoxifloxacinDrug

    Moxifloxacin is a fourth-generation fluoroquinolone with potent activity against M. tuberculosis in vitro and in vivo, 400mg (7.5-10mg/kg/d)

Study groups in NCT05454345
Study groupRoleWhat they receive
The three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin-containing regimenExperimentalThirteen weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin.
Receives: Drug: Sitafloxacin; Drug: Pyrazinamide; Drug: Rifapentine; Drug: Isoniazid
The three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin&SMZ/TMP-containing regimenExperimentalSix weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ/TMP and Sitafloxacin.
Receives: Drug: Sitafloxacin; Drug: SMZ/TMP; Drug: Pyrazinamide; Drug: Rifapentine; Drug: Isoniazid
The six-month standard Rifampin&Isoniazid&Pyrazinamide&Ethambutol-containing regimenActive comparatorEight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid.
Receives: Drug: Rifampin; Drug: Pyrazinamide; Drug: Isoniazid; Drug: Ethambutol
The four-month Rifapentine&Isoniazid&Pyrazinamide&Moxifloxacin -containing regimenActive comparatorEight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin.
Receives: Drug: Rifapentine; Drug: Isoniazid; Drug: Ethambutol; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TB Disease-free Survival after the completion of the treatment cycle.

    To evaluate the efficacy of a Sitafloxacin-containing regimen to determine whether the substitution of Sitafloxacin for moxifloxacin could shorten the treatment duration from 6 months to 3 months (13 weeks) for drug-susceptible pulmonary tuberculosis. Pathogen detection (including sputum smear and sputum culture) should complete in Week 13 in the three-month regimen group, Week 17 in the four-month regimen group, and Week 26 in the standard six-month regimen group.

    Measured: Week 13 in the three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin-containing regimen and three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin&SMZ/TMP-containing regimen

  2. TB Disease-free Survival after the completion of the treatment cycle.

    To evaluate the efficacy of a Sitafloxacin-containing regimen to determine whether the substitution of Sitafloxacin for moxifloxacin could shorten the treatment duration from 6 months to 3 months (13 weeks) for drug-susceptible pulmonary tuberculosis. Pathogen detection (including sputum smear and sputum culture) should complete in Week 13 in the three-month regimen group, Week 17 in the four-month regimen group, and Week 26 in the standard six-month regimen group.

    Measured: Week 17 in the four-month Rifapentine&Isoniazid&Pyrazinamide&Moxifloxacin -containing regimen

  3. TB Disease-free Survival after the completion of the treatment cycle.

    To evaluate the efficacy of a Sitafloxacin-containing regimen to determine whether the substitution of Sitafloxacin for moxifloxacin could shorten the treatment duration from 6 months to 3 months (13 weeks) for drug-susceptible pulmonary tuberculosis. Pathogen detection (including sputum smear and sputum culture) should complete in Week 13 in the three-month regimen group, Week 17 in the four-month regimen group, and Week 26 in the standard six-month regimen group.

    Measured: Week 26 in the six-month standard Rifampin&Isoniazid&Pyrazinamide&Ethambutol-containing regimen

  4. Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen

    To determine Grade 3 or higher adverse events in study participants during drug treatment in the standard six-month regimen, the four-month regimen, and the three-month regimen Sitafloxacin-containing and three-month Sitafloxacin\&SMZ/TMP-containing regimen

    Measured: Week 13 in the three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin-containing regimen and three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin&SMZ/TMP-containing regimen

  5. Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen

    To determine Grade 3 or higher adverse events in study participants during drug treatment in the standard six-month regimen, the four-month regimen, and the three-month regimen Sitafloxacin-containing and three-month Sitafloxacin\&SMZ/TMP-containing regimen

    Measured: Week 17 in the four-month Rifapentine&Isoniazid&Pyrazinamide&Moxifloxacin -containing regimen

  6. Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen

    To determine Grade 3 or higher adverse events in study participants during drug treatment in the standard six-month regimen, the four-month regimen, and the three-month regimen Sitafloxacin-containing and three-month Sitafloxacin\&SMZ/TMP-containing regimen

    Measured: Week 26 in the six-month standard Rifampin&Isoniazid&Pyrazinamide&Ethambutol-containing regimen

Secondary outcomes (2)

  1. The rates of negative sputum conversion

    The rates of negative sputum conversion will be determined at the end of 2 months using the sputum smear and culture test.

    Measured: two months

  2. TB disease-free survival at six and twelve months after study treatment assignment.

    The rates of TB disease-free survival at six and twelve months

    Measured: Twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05454345
Sponsor's protocol ID
yzhang207
Status last verified
Jul 2022
First submitted
17 Jun 2022
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis: 2011 Update. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK148644/

    PubMed 23844450

  • Gupta VK, Kumar MM, Singh D, Bisht D, Sharma S. Drug targets in dormant Mycobacterium tuberculosis: can the conquest against tuberculosis become a reality? Infect Dis (Lond). 2018 Feb;50(2):81-94. doi: 10.1080/23744235.2017.1377346. Epub 2017 Sep 21.

    PubMed 28933243

  • Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002.

    PubMed 11432536

  • Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.

    PubMed 33951360

  • Keating GM. Sitafloxacin: in bacterial infections. Drugs. 2011 Apr 16;71(6):731-44. doi: 10.2165/11207380-000000000-00000.

    PubMed 21504249

  • Yamaguchi K, Ohno A, Ishii Y, Tateda K, Iwata M, Kanda M, Akizawa K, Shimizu C, Kon S, Nakamura K, Matsuda K, Tominaga M, Nakagawa T, Sugita A, Ito T, Kato J, Suwabe A, Yamahata K, Kawamura C, Tashiro H, Horiuchi H, Katayama Y, Kondou S, Misawa S, Murata M, Kobayashi Y, Okamoto H, Yamazaki K, Okada M, Haruki K, Kanno H, Aihara M, Maesaki S, Hashikita G, Miyajima E, Sumitomo M, Saito T, Yamane N, Kawashima C, Akiyama T, Ieiri T, Yamamoto Y, Okamoto Y, Okabe H, Moro K, Shigeta M, Yoshida H, Yamashita M, Hida Y, Takubo T, Kusakabe T, Masaki H, Heijyou H, Nakaya H, Kawahara K, Sano R, Matsuo S, Kono H, Yuzuki Y, Ikeda N, Idomuki M, Soma M, Yamamoto G, Kinoshita S, Kawano S, Oka M, Kusano N, Kang D, Ono J, Yasujima M, Miki M, Hayashi M, Okubo S, Toyoshima S, Kaku M, Sekine I, Shiotani J, Horiuchi H, Tazawa Y, Yoneyama A, Kumasaka K, Koike K, Taniguchi N, Ozaki Y, Uchida T, Murakami M, Inuzuka K, Gonda H, Yamaguchi I, fujimoto Y, Iriyama J, Asano Y, Genma H, Maekawa M, Yoshimura H, Nakatani K, Baba H, Ichiyama S, Fujita S, Kuwabara M, Okazaki T, Fujiwara H, Ota H, Nagai A, Fujita J, Negayama K, Sugiura T, Kamioka M, Murase M, Yamane N, Nakasone I, Okayama A, Aoki Y, Kusaba K, Nakashima Y, Miyanohara H, Hiramatsu K, Saikawa T, Yanagihara K, Matsuda J, Kohno S, Mashiba K. [In vitro susceptibilities to levofloxacin and various antibacterial agents of 12,919 clinical isolates obtained from 72 centers in 2007]. Jpn J Antibiot. 2009 Aug;62(4):346-70. Japanese.

    PubMed 19860322

  • Asakura T, Suzuki S, Fukano H, Okamori S, Kusumoto T, Uwamino Y, Ogawa T, So M, Uno S, Namkoong H, Yoshida M, Kamata H, Ishii M, Nishimura T, Hoshino Y, Hasegawa N. Sitafloxacin-Containing Regimen for the Treatment of Refractory Mycobacterium avium Complex Lung Disease. Open Forum Infect Dis. 2019 Mar 7;6(4):ofz108. doi: 10.1093/ofid/ofz108. eCollection 2019 Apr.

    PubMed 31111076

  • Ito S, Yasuda M, Seike K, Sugawara T, Tsuchiya T, Yokoi S, Nakano M, Deguchi T. Clinical and microbiological outcomes in treatment of men with non-gonococcal urethritis with a 100-mg twice-daily dose regimen of sitafloxacin. J Infect Chemother. 2012 Jun;18(3):414-8. doi: 10.1007/s10156-012-0392-9. Epub 2012 Feb 28.

    PubMed 22370921

  • Mori H, Suzuki H, Matsuzaki J, Masaoka T, Kanai T. 10-Year Trends in Helicobacter pylori Eradication Rates by Sitafloxacin-Based Third-Line Rescue Therapy. Digestion. 2020;101(5):644-650. doi: 10.1159/000501610. Epub 2019 Aug 6.

    PubMed 31387107

  • Li Y, Zhu D, Peng Y, Tong Z, Ma Z, Xu J, Sun S, Tang H, Xiu Q, Liang Y, Wang X, Lv X, Dai Y, Zhu Y, Qu Y, Xu K, Huang Y, Wu S, Lai G, Li X, Han X, Yang Z, Sheng J, Liu Z, Li H, Chen Y, Zhu H, Zhang Y. A randomized, controlled, multicenter clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus moxifloxacin in adult patients with community-acquired pneumonia. Curr Med Res Opin. 2021 Apr;37(4):693-701. doi: 10.1080/03007995.2021.1885362. Epub 2021 Feb 22.

    PubMed 33534617

  • Leechawengwongs M, Prammananan T, Jaitrong S, Billamas P, Makhao N, Thamnongdee N, Thanormchat A, Phurattanakornkul A, Rattanarangsee S, Ratanajaraya C, Disratthakit A, Chaiprasert A. In Vitro Activity and MIC of Sitafloxacin against Multidrug-Resistant and Extensively Drug-Resistant Mycobacterium tuberculosis Isolated in Thailand. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e00825-17. doi: 10.1128/AAC.00825-17. Print 2018 Jan.

    PubMed 29061759

  • Kamada K, Yoshida A, Iguchi S, Arai Y, Uzawa Y, Konno S, Shimojima M, Kikuchi K. Nationwide surveillance of antimicrobial susceptibility of 509 rapidly growing mycobacteria strains isolated from clinical specimens in Japan. Sci Rep. 2021 Jun 9;11(1):12208. doi: 10.1038/s41598-021-91757-4.

    PubMed 34108590

  • Yi L, Aono A, Chikamatsu K, Igarashi Y, Yamada H, Takaki A, Mitarai S. In vitro activity of sitafloxacin against Mycobacterium tuberculosis with gyrA/B mutations isolated in Japan. J Med Microbiol. 2017 Jun;66(6):770-776. doi: 10.1099/jmm.0.000493.

    PubMed 28598311

  • Suzuki Y, Nakajima C, Tamaru A, Kim H, Matsuba T, Saito H. Sensitivities of ciprofloxacin-resistant Mycobacterium tuberculosis clinical isolates to fluoroquinolones: role of mutant DNA gyrase subunits in drug resistance. Int J Antimicrob Agents. 2012 May;39(5):435-9. doi: 10.1016/j.ijantimicag.2012.01.007. Epub 2012 Mar 13.

    PubMed 22421328

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitafloxacin, SMZ/TMP and Rifampin in people with Tuberculosis, Pulmonary, run by First Affiliated Hospital of Zhejiang University.

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 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

TB Disease-free Survival after the completion of the treatment cycle. (time frame: Week 13 in the three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin-containing regimen and three-month Rifapentine&Isoniazid&Pyrazinamide&Sitafloxacin&SMZ/TMP-containing regimen). The study lists 6 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 NCT05454345, which also lists 14 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 12 Jul 2022.

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