Clinical outcomes of contezolid in treating complex tuberculosis: real-world evidence from 11 patients
Highlight box
Key findings
• Contezolid demonstrated clinical efficacy in the treatment of tuberculosis (TB).
• Patients who could not tolerate linezolid (Lzd) or had contraindications to it benefited from contezolid-containing regimens.
• Contezolid exhibited a superior safety profile compared to Lzd.
What is known and what is new?
• Lzd is an effective treatment for TB, but it is associated with significant adverse events. The in vitro antimicrobial activity of contezolid against Mycobacterium tuberculosis is comparable to that of Lzd.
• This study provides clinical evidence supporting the use of contezolid as a safer alternative to Lzd in patients with drug-sensitive TB, particularly in cases with complex medical conditions or intolerance to standard treatments.
What is the implication, and what should change now?
• Contezolid should be considered as an alternative to Lzd in the treatment of TB, especially for patients who experience severe side effects or contraindications to standard therapies.
• Further large-scale clinical studies need to be conducted to confirm its efficacy and safety in broader TB populations.
Introduction
Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis (MTB), accounts for a considerable number of deaths annually and remains a significant global health concern (1). As indicated in the 2022 TB report published by the World Health Organization (WHO), China has the third highest number of new TB cases worldwide annually (2).
In the treatment of drug-sensitive TB, first-line anti-TB drugs are still preferred, of which, isoniazid (H), rifampicin (R), ethambutol (E), and pyrazinamide (Z) are the most commonly used in a 6-month regimen with Z given for the first 2 months (3). More recently, a 4-month regimen comprised of H, rifapentine (Dl), moxifloxacin (Mfx), and Z (first 2 months only) has been recommended (4). However, some TB patients experience intolerable adverse events (AEs) when using first-line anti-TB drugs (5). Consequently, they require adjustment to their regimen that may include addition of one or more second-line agents. This highlights the clinical demand for new anti-TB drugs with higher safety.
Linezolid (Lzd) is an oxazolidinone antibiotic with potent anti-bacterial activity against MTB. It is classified as one of the core Group A drugs for the treatment of drug-resistant TB and is also recommended for the treatment of severe TB, such as intracranial TB, or for special populations who are intolerant with the use of first-line anti-TB drugs (6,7). The most commonly reported AEs of Lzd include gastrointestinal reactions, bone marrow suppression, peripheral neuritis, and optic neuritis (8). The anemia, leukopenia, and/or thrombocytopenia associated with long-term use of Lzd frequently limit its use. Additionally, liver and kidney toxicities have rarely been observed.
Contezolid represents a novel class of oxazolidinone antibiotics. Research has shown that the active moiety of contezolid is identical to that of Lzd (9). Both compounds exhibit comparable molecular structures and mechanisms of action. In vitro study has shown that the bactericidal efficacy of contezolid is analogous to that of Lzd, and that the drug is bactericidal against MTB (10). Importantly, the bone marrow suppression and neurotoxicity observed with contezolid are significantly lower than that observed with Lzd (11,12), while liver and kidney toxicities remain rare (13). However, there is a paucity of reported experience on the use of contezolid in combination therapy for patients with drug-sensitive TB but are intolerant to one or more drugs in first-line anti-TB regimens. Thus, we retrospectively analyzed our experience of 11 patients admitted to the Second Hospital of Nanjing with active TB in whom contezolid was included in their regimen because they were either intolerant or had relative contraindications to drugs included in the first-line TB treatment regimens. We present this article in accordance with the AME Case Series and STROBE reporting checklists (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-878/rc).
Methods
Study participants
The medical record management system was used to obtain data for our analysis of drug-sensitive TB patients admitted to the Second Hospital of Nanjing between March 1, 2022 and March 1, 2024. All MTB isolates underwent TB drug susceptibility testing. A total of 11 patients, who had been prescribed an anti-TB regimen containing contezolid during the course of their treatment due to intolerance of other anti-TB drugs, were retrospectively identified for inclusion in the study. The data collected for each patient included basic demographic information, clinical details, laboratory test results including sputum culture. This data was then subjected to retrospective analysis and descriptive evaluation for the measurements for treatment outcomes and safety outcomes. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the Second Hospital of Nanjing (SN: 2023-LS-021) and informed consent was taken from all the patients.
Inclusion criteria
To be eligible for inclusion in the study, the patients had to meet the following inclusion criteria: (I) have a clinical, microbiological, or histopathological diagnosis of TB; and (II) have undergone TB drug susceptibility testing that confirmed the sensitivity of all the background drug medications; and (III) have received contezolid combined with other anti-TB drugs as part of an anti-TB treatment regimen.
Exclusion criteria
Patients were excluded from the study if they met any of the following exclusion criteria: (I) had drug-resistant TB; (II) had their anti-TB treatment program with contezolid interrupted; and/or (III) used contezolid for less than one month.
Treatment regimens
In formulating the initial anti-TB regimen, the clinician considered each patient’s general condition, history of drug allergies, and past medical history to develop a personalized anti-TB regimen. Contezolid was employed in conjunction with other background anti-TB medications at a dosage of 800 mg once or twice daily based on the patient’s overall condition. A revised anti-TB regimen was developed for each patient based on their general conditions and clinical history. The prior regimen(s) included one or more of the following anti-TB drugs: H, R, E, Z, Dl, Mfx, levofloxacin (Lfx), clofazimine (Cfz), and/or cycloserine (Cs). Treatment outcomes were assessed through: (I) sputum acid-fast bacilli (AFB) smear and culture conversion from positive to negative, with culture conversion defined as two consecutive negative cultures collected at least 30 days apart; (II) improvement in clinical symptoms such as cough, fever, and fatigue. Follow-up was performed monthly during hospitalization and outpatient treatment until completion of the treatment regimen.
The efficacy and prognosis of the treatment were assessed based on the results of sputum acid-fast smears, MTB cultures, clinical symptoms, and imaging findings obtained after each patient had received treatment.
Safety evaluation
The assessment of AEs was based on complete blood count, electrolytes, and renal and liver function tests as well as manifestation of clinical symptoms. In accordance with the WHO standard for AEs classification (grades 1–5), grades 1 and 2 AEs were classified as mild to moderate, while grades 3–5 AEs were classified as severe (grade 3: serious; grade 4: life-threatening; grade 5: death).
Statistical analysis
The data were analyzed using the statistical software package SPSS 26.0 (IBM, Armonk, NY, USA), and a descriptive analysis was performed. Categorical variables are expressed as counts and percentages. Continuous variables are expressed as averages.
Results
Patient characteristics
The median age of the 11 patients was 53 years (range, 27–77 years), including six males and five females. All patients presented with drug-sensitive TB. Of the 11 patients, four had pulmonary TB, six had multiorgan TB, and one had TB of the lymph nodes. The prior antimicrobial treatments of TB were taken into consideration when selecting the first- and second-lines of anti-TB treatment. However, due to adverse drug reactions during the anti-TB treatment or relative contraindications to one or more of the anti-TB first-line drugs, an effective anti-TB treatment could not be established. In these patients, the addition of contezolid as part of an anti-TB treatment regimen was identified. The background anti-TB drugs included: H, R, E, Z, Dl, Lfx, Mfx, Lzd, Cfz, and Cs. Following anti-TB therapy with contezolid, all patients showed improvement during the follow-up period (Table 1).
Table 1
| Variables | Statistics |
|---|---|
| Average/median age (years) | 53/53 |
| Male/female ratio, n | 6/5 |
| Pulmonary TB/multi-organ TB, n | 4/7 |
| Underlying disease (%) | |
| Liver disease | 27 |
| Diabetes mellitus | 18 |
| Hematologic disease | 36 |
| Kidney disease | 27 |
| Autoimmune disease | 9 |
| Treatment outcome (%) | |
| Improved | 100 |
| Sputum pathology results for M. tuberculosis, n | |
| Positive | 10/11 |
| Negative | 1/11 |
M. tuberculosis, Mycobacterium tuberculosis; TB, tuberculosis.
Treatment regimens
Initial anti-TB regimens were individualized based on clinical status, comorbidities, and prior drug exposure. The most frequently used background drugs included H (100%), R (72.7%), E (72.7%), and Z (63.6%) (Table 2). Due to either intolerance or relative contraindications to first-line drugs, all 11 patients with drug-susceptible TB included ultimately received the anti-TB treatment regimen containing contezolid. Five patients received a regimen containing contezolid at the initial stage of its formulation due to their relative contraindications to Lzd use, while the remaining six patients were initially prescribed anti-TB regimens containing Lzd, but were compelled to switch to the regimen containing contezolid due to the emergence of severe AEs. Contezolid was administered at 800 mg once daily (qd) or twice daily (bid), in combination with other background anti-TB drugs (Table 3).
Table 2
| Drugs | Initial treatment regimen background drug use (%) | Adjusted regimen background drug use (%) |
|---|---|---|
| H | 100 | 100 |
| R | 72.7 | 18.2 |
| E | 72.7 | 54.5 |
| Z | 63.6 | 36.4 |
| Lzd | 54.5 | 0 |
| Mfx | 63.6 | 36.4 |
| Dl | 9 | 18.2 |
| Lfx | 18.2 | 36.4 |
| Cs | 0 | 9.1 |
| Cfz | 0 | 9.1 |
| Czd | 0 | 100 |
Cfz, clofazimine; Cs, cycloserine; Czd, contezolid; Dl, rifapentine; E, ethambutol; H, isoniazid; Lfx, levofloxacin; Lzd, linezolid; Mfx, moxifloxacin; R, rifampicin; TB, tuberculosis; Z, pyrazinamide.
Table 3
| No. | Sex/age (years) | Diagnosis | Anti-TB regimen | Lzd-related contraindication | Anti-TB drug-related AEs | Time to AEs | AE grade | Czd | Outcome | Comment | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AEs | Sputum culture results for MTB | Symptom | ||||||||||
| 1 | F/27 | Multi-organ TB | H, R, E, Z, Lzd for 2 weeks; H, E, Z, Lzd for 4 weeks; H, R, Z, Lfx, Czd | None | Drug fever, gastrointestinal disorders | 2 weeks | Grade 2, moderate | 800 mg, bid | CR | Negative | Improved | Because of the patient’s recurrent fever, linezolid was initially considered |
| 2 | F/41 | PTB | H, R, Mfx for 8 weeks; H, R, Mfx, Lzd for 11 weeks; H, R, Mfx, Czd | None | Myelosuppression | 11 weeks | Grade 2, moderate | 800 mg, qd | CR | Negative | Improved | Due to renal insufficiency, the use of E and Z was avoided. Lzd was added because of the progression of the lung lesions |
| 3 | M/53 | Multi-organ TB | H, R, E, Mfx for 1 week; H, R, E, Mfx, Lzd for 31 weeks; H, Lfx, Czd | None | Peripheral neuropathy, arthralgia | 31 weeks | Grade 2, moderate | 800 mg, qd | CR | Negative | Improved | Extensive lung lesions and the failure of the initial treatment regimen to relieve symptoms led to the consideration of linezolid |
| 4 | M/68 | PTB | H, Dl for 1 week; H, Dl, Z for 1 week; H, Dl, Z, Czd | Severe anemia | – | – | – | 800 mg, qd | – | Negative | Improved | Underlying diseases limited the use of TB drugs to form an effective treatment program |
| 5 | M/77 | Multi-organ TB | H, R, E, Mfx, Lzd for 1 week; H, E, Mfx, Lzd for 2 weeks; H, E, Czd, Cs | None | Hepatotoxicity, myelosuppression | 1 week | Grade 3, severe thrombocytopenia; grade 2, hepatotoxicity | 800 mg, qd | CR | Negative | Improved | As the patient was critically ill with severe hematogenous disseminated TB involving multiple organs, linezolid was initially selected |
| 6 | M/60 | Multi-organ TB | H, R, E, Z for 1 week; H, R, E, Z, Mfx, Lzd for 1 week; H, R, E, Lfx, Lzd for 1 week; H, Dl, E, Lzd for 1 week; H, Dl, E, Czd | None | Gastrointestinal disorders, hepatotoxicity, myelosuppression, severe hypokalemia: <2.4 mmol/L | 1 week | Grade 2, moderate, gastrointestinal disorders; grade 2, moderate, hepatotoxicity; grade 3, myelosuppression | 800 mg, qd | CR | Negative | Improved | – |
| 7 | F/53 | Lymph node TB | H, R, E, Z for 3 weeks; H, E, Lfx, Czd | Coagulation disorders | Drug allergy, hepatotoxicity, myelosuppression | 3 weeks | Grade 3, severe, dermatologic disorders; grade 2, moderate, hepatotoxicity; grade 4, severe myelosuppression | 800 mg, qd | PR | Negative | Improved | – |
| 8 | F/49 | PTB | H, E, Mfx for 1 week; H, E, Mfx, Czd, Cfs | Leukemia | – | – | – | 800 mg, qd | – | Negative | Improved | The initial treatment regimen did not improve symptoms |
| 9 | M/59 | PTB | H, E, Z, Mfx for 1 week; H, E, Z, Lfx, Czd | Leukemia | Gastrointestinal disorders | 1 week | Grade 2, moderate | 800 mg, qd | CR | Negative | Improved | Hematologic disorders limited R use |
| 10 | M/46 | Multi-organ TB | H, R, Z, Mfx for 2 days; H, Z, Mfx, Lzd for 10 days; H, Mfx, Lzd for 4 days; H, Mfx, Z, Czd | None | Drug fever, hepatotoxicity, myelosuppression | 2 days | Grade 4 | 800 mg bid for 2 weeks; 800 mg qd | PR | Negative | Improved | Renal insufficiency limited E use |
| 11 | F/55 | Multi-organ TB | H, R, E, Z for 4 months; Lfx for 2 months; H, E, Mfx, Czd | Leucopenia | Liver failure | 4 months | Grade 4 | 800 mg, qd | PR | Negative | Improved | – |
AEs, adverse events; Cfz, clofazimine; CR, complete remission; Cs, cycloserine; Czd, contezolid; Dl, rifapentine; E, ethambutol; F, female; H, isoniazid; Lfx, levofloxacin; Lzd, linezolid; M, male; Mfx, moxifloxacin; PR, partial remission; PTB, pulmonary tuberculosis; R, rifampicin; TB, tuberculosis; Z, pyrazinamide.
Treatment outcomes and safety outcomes
All 11 patients who received contezolid as part of their anti-TB regimen had improved clinical symptoms. Among the 10 patients who were initially sputum culture-positive, all converted to negative status following treatment. One patient remained culture-negative throughout.
We examined the initial drug-related AEs information of 11 patients (Table 4). The mean time from the initiation of treatment to the occurrence of anti-TB drug-related AEs was 47 days (6.6 weeks) at follow-up for all the 11 patients. The mean time to Lzd-related AEs in the six patients receiving the Lzd-containing regimen was 62 days (8.9 weeks) (Table 3). In the other five patients who received the contezolid-containing treatment regimen, no serious AEs were observed during the follow-up treatment, and their prognosis was favorable. In accordance with the established definitions and grading of drug-related AEs, a summary and analysis were conducted (Table 4).
Table 4
| Parameters | Proportion |
|---|---|
| Time from anti-TB to anti-TB drug related AEs | |
| None | 2/11 |
| <1 month | 6/11 |
| ≥1 and <3 months | 1/11 |
| ≥3 months | 2/11 |
| Type of anti-TB drug-related AEs | |
| Gastrointestinal disorder | 3/11 |
| Hepatotoxicity | 4/11 |
| Peripheral neuropathy | 1/11 |
| Drug fever | 2/11 |
| Arthralgia | 1/11 |
| Myelosuppression | 4/11 |
| Skin and appendages disorders | 1/11 |
| Other | 1/11 |
| AEs grade | |
| Grade 1 | 0 |
| Grade 2 | 8/11 |
| Grade 3 | 3/11 |
| Grade 4 | 3/11 |
| Grade 5 | 0 |
| AEs outcome after switching to contezolid-containing treatment | |
| Complete resolution | 6/11 |
| Significant resolution | 0 |
| Partial resolution | 3/11 |
| Ongoing | 0 |
AEs, adverse events; TB, tuberculosis.
Discussion
As indicated in the WHO TB Science Report 2024, TB remains the leading cause of mortality from infectious diseases globally, and thus represents a danger to the public health security of all human societies (2). H, R, E, Z combination therapy is the recommended treatment for drug-sensitive TB (3); however, drug-related AEs frequently restrict the range of available drugs and the options for treatment. The selection of appropriate TB drugs is frequently constrained for individuals with underlying immunocompromising conditions, thereby impeding the formation of an efficacious anti-TB treatment regimen. This ultimately leads to an inability to control the disease in a timely manner, resulting in the progression of TB and a poorer prognosis. Consequently, treatment of TB in certain populations may necessitate modifications of the anti-TB regimens.
The WHO lists Lzd as a Group A drug, indicating that it can be used in combination with other anti-TB drugs in the treatment of drug-resistant TB. Lzd is frequently recommended for the treatment of refractory TB and multidrug-resistant (MDR)-TB (6,7,11). A substantial body of clinical evidence indicates that Lzd plays a pivotal role in the management of MDR-TB. Lzd-associated AEs have been reported in 42.45% of patients with TB started on a Lzd-based regimen for the treatment of drug-resistant TB under real-world conditions, and only 20% of these patients were able to continue to receive the unmodified Lzd dose as part of the anti-TB treatment regimen (8). However, the AEs of Lzd, particularly bone marrow suppression and peripheral neuropathy, frequently restrict its use. Consequently, Lzd may be relatively contraindicated for TB patients with specific underlying comorbidities.
The 11 patients included in this study presented with refractory TB due to serious underlying diseases, critical TB, and difficult-to-control clinical symptoms. Six patients elected to use Lzd as part of their therapeutic regimen; however, all these patients were compelled to discontinue its use due to AEs associated with Lzd.
Contezolid, a new oxazolidinone antibacterial agent, was approved by the National Medical Products Administration of China in June 2021 for the treatment of complicated skin and soft tissue infections, including infections involving methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes, and Streptococcus agalactiae (9). As a new generation of oxazolidinone antibiotics, in vitro and in vivo experimental study showed that contezolid exerts a pronounced bactericidal effect and efficacy against MTB and TB, respectively (10). Furthermore, a substantial body of evidence indicates that contezolid is safer than Lzd (14). Consequently, it is regarded as a potential alternative to Lzd for patients with refractory TB and MDR-TB who experience intolerable side effects during treatment (11,15).
A previous study showed that both contezolid and Lzd exhibited comparable efficacy against the 50% minimal inhibit concentration (MIC50) and MIC90 of MTB (9). Further, both drugs inhibited the growth of MTB in macrophages in a dose-dependent manner. In relation to the reduction of colony-forming units, the performance of contezolid was more pronounced than that of Lzd. The chemical structure of contezolid renders its adverse effect on bone marrow markedly less than that affected by Lzd, a finding that was corroborated in the present study (12). Moreover, in vitro drug susceptibility tests have also shown that contezolid exhibits in vitro antibacterial activity against the majority of MTB (16,17).
The limitations of this study include the absence of a control group and the relatively small number of patients in our cohort, resulting in the inability to generalize our findings to a larger population. Nevertheless, this promising study provides the impetus to conduct further larger controlled clinical trials to confirm the long-term efficacy and safety of contezolid in various TB patient populations.
Conclusions
Contezolid has been shown to exert a comparable anti-TB effect to that of Lzd in patients with drug-sensitive TB. Further, contezolid has been shown to possess safety and tolerability profiles than Lzd. Thus, for certain TB patients with severe underlying diseases or severe TB, or for patients whose treatment is interrupted due to serious drug-related AEs, contezolid may be a preferred option when combined with other anti-TB drugs. While these findings are promising, future well-designed, larger-scale clinical trials are needed to confirm the long-term efficacy and safety of contezolid in various TB patient populations. Additionally, contezolid is promising for use in the treatment of drug-resistant TB.
Acknowledgments
None.
Footnote
Reporting Checklist: The authors have completed the AME Case Series and STROBE reporting checklists. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-878/rc
Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-878/dss
Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-878/prf
Funding: This study was supported by
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-878/coif). E.D.C. serves as an unpaid editorial board member of Journal of Thoracic Disease from February 2025 to January 2027. The other authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of the Second Hospital of Nanjing (SN: 2023-LS-021) and informed consent was taken from all the patients.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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