Status:
COMPLETED
EBA, Safety and Tolerability of Sanfetrinem Cilexetil
Lead Sponsor:
TASK Applied Science
Collaborating Sponsors:
GlaxoSmithKline
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the 2-week bactericidal activity, pharmacokinetics, safety and tolerability of sanfetrinem cilexetil in participants with rifampicin-susceptible pulmonary tuberculosis.
Detailed Description
A single-centre, open-label, clinical trial in two stages. Stage 1 will recruit 20 participants followed by a recruitment pause and an interim analysis to determine if sanfetrinem cilexetil has early ...
Eligibility Criteria
Inclusion
- Participants are required to meet all of the following criteria in order to be randomized.
- Provide written, informed consent prior to all trial-related procedures.
- Male or female, aged between 18 and 65 years, inclusive.
- Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
- Newly diagnosed, previously untreated, rifampicin-susceptible pulmonary TB.
- A chest X-ray picture taken at screening which, in the opinion of the investigator, is consistent with TB.
- Sputum positive on direct microscopy for acid-fast bacilli on at least one sputum sample (at least 1+ on the IUATLD/WHO scale) or GeneXpert cycle threshold of medium or high.
- Ability to produce an adequate volume of sputum as estimated from an overnight sputum collection sample (estimated 10 ml or more).
- Be of non-childbearing potential or using effective methods of birth control, as defined below:
- Non-childbearing potential:
- Female participant/ female sexual partner - bilateral oophorectomy
- bilateral tubal ligation
- hysterectomy
- postmenopausal with no menses for at least 12 consecutive months Male participant/ male sexual partner - vasectomy
- bilateral orchidectomy more than three months prior to screening
- Effective birth control methods:
- Participant is not heterosexually active or practicing sexual abstinence
- Double barrier method which can include a male condom, diaphragm, cervical cap, or female condom (male and female condoms should not be used together); or
- Barrier method combined with hormone-based contraceptives or an intra-uterine device for the female partner.
Exclusion
- Participants will be excluded from participation if they fulfil any of the following criteria.
- Evidence of clinically significant conditions or findings, other than TB, that might compromise safety or the interpretation of trial endpoints, per discretion of the investigator.
- Poor general condition where any delay in treatment cannot be tolerated per discretion of the investigator.
- Clinically significant evidence of extrathoracic TB, as judged by the investigator.
- History of allergy to any of the trial IP/s or related substances i.e. β-lactams and penicillin, as confirmed by the clinical judgement of the investigator.
- Alcohol or drug abuse, that in the opinion of the investigator, is sufficient to compromise the safety or cooperation of the participant.
- HIV positive ONLY IF:
- CD4 \< 250cells/mm3
- On ART
- Participation in other clinical studies with investigational agents within 8 weeks prior to trial start (with the exception of COVID-19 vaccines).
- Female participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of trial participation. Male participant planning to conceive a child within the anticipated period of participating in the trial.
- Treatment received with any drug active against M.tb (including but not limited to isoniazid, ethambutol, amikacin, cycloserine, fluoroquinolones, rifabutin, rifampicin, streptomycin, kanamycin, para-aminosalicylic acid, rifapentine, pyrazinamide, thioacetazone, capreomycin, thioamides), or with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
- Participants with the following toxicities at screening as defined by the enhanced CTCEA toxicity table
- creatinine \>1.5 times upper limit of normal \[ULN\];
- haemoglobin \<8.0 g/dL;
- platelets \<50x109 cells/L;
- serum potassium \<3.0 mmol/L;
- aspartate aminotransferase (AST) ≥3.0 x ULN;
- alanine aminotransferase (ALT) ≥3.0 x ULN;
- Total white cell count \<1.5 cells/L
- For participants undergoing PET/CT, the following are excluded:
- Participants with diabetes (Type 1 or 2) with point of care HbA1c above 6.5, or random glucose over 11.1 mmol/L.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05388448
Start Date
April 21 2022
End Date
August 19 2024
Last Update
February 21 2025
Active Locations (1)
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1
TASK Clinical Research Centre
Cape Town, Western Cape, South Africa, 7530