Health TrialsbyHealthPanel

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

ConditionMycobacterium Avium Complex Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBin Cao

About this trial

The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are:

Does adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease?

Participants will:

Take contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months.

Visit the clinic once every 1 month for checkups and tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily participate in this study and sign the Informed Consent Form.

Age ≥ 18 years and ≤75 years; gender unrestricted.

Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with nodular bronchiectatic type.

No prior anti-MAC treatment within the 3 months preceding screening.

Disqualifiers

History of allergy to any study drug in the treatment regimen.

Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).

Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy/radiation therapy during the screening or study period.

History of solid organ transplantation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Contezolid

    Drug

    contezolid 800mg po q12h\*6m

  • Azithromycin

    Drug

    azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m

  • Azithromycin

    Drug

    azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m

  • Ethambutol (E)

    Drug

    ethambutol 25mg/kg po tiw\*6m

  • Ethambutol (E)

    Drug

    ethambutol 25mg/kg po tiw\*12m

  • Rifampicin (R)

    Drug

    rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m

  • Rifampicin (R)

    Drug

    rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Contezolid shortened regimenExperimental treatment 4 interventions
Group B: Standard regimenActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

culture conversion

2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.

Time frame
end of month 6
2

CT lesion absorption

\>30% decrease in lesion size or number of nodules measured on CT

Time frame
end of month 6
3

QOL-B+NTM module

Improvement greater than MID in at least 7 out of 12 domains in QOL-B with NTM-module (must include respiratory symptoms and NTM-PD symptoms)

Time frame
end of month 6

Secondary outcomes

1

culture conversion

2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.

Time frame
up to month 12
2

CT lesion status

\>30% decrease in lesion size or number of nodules measured on CT

Time frame
end of month 3, 6, and 12 (for standard regimen)/end of month 3 and 6 (for shortened regimen)
3

Questionnaire: Quality of life-bronchiectasis (QOL-B) and NTM module

Improvement greater than minimal importance difference in at least 7 out of 12 domains in QOL-B with NTM module (must include respiratory symptoms and NTM-PD symptoms)

Time frame
up to month 12
4

SGRQ

Time frame
up to month 12

Other outcomes

1

Number of participants with adverse events

Adverse events related to study intervention (short-term regimen and standard regimen) are reported by participants.

Time frame
up to month 12
2

MAC strain drug-sensitivity

Phenotypic drug sensitivity will be evaluated with microdilution method for macrolides, amikacin, rifampicin, and ethanmbutol

Time frame
end of month 6 (for shortened regimen)/end of month 12 (for standard regimen)
3

Number of participants with treatment-related abnormal laboratory tests results

Laboratory tests include complete blood count, liver function and kidney function. Abnormalities will be recorded and discussed to determine the causality between treatment and laboratory findings.

Time frame
up to month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bin Cao

Lead sponsor

Capital Medical University

Sponsor institution

MicuRx

Collaborator

Shanghai Pulmonary Hospital, Shanghai, China

Collaborator

Beijing Chest Hospital

Collaborator

Anhui Chest Hospital

Collaborator

Jiangxi Chest Hospital

Collaborator

Guangzhou Chest Hospital.

Collaborator

Source ClinicalTrials.gov
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