SQ109 EBA

Not Applicable

Recruiting

• Conditions: Tuberculosis

• Registration Number: PACTR201009000252144
• Lead Sponsor: Prof. Burkhard Göke, Medical Director, Klinikum of the University of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Provide signed written informed consent for study participation, including HIV testing (if HIV serostatus is not known or the last documented negative is more than four weeks prior to enrolment).
2.Be eighteen (18) to 64 (inclusive) years of age.
3.Have a body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
4.Have newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
5.Have a chest X-ray which, in the opinion of the Investigator, is compatible with TB.
6.Is sputum positive on direct microscopy for acid-fast bacilli (at least 1+ on the IUATLD/WHO scale (Appendix 3).
7.Is able to produce an adequate spot sputum sample, indicating an overnight sputum volume of at least 10 mL.
8.Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice two effective methods of birth control when not abstaining from sexual intercourse, unless she and her partner(s) are surgically sterile or she is post-menopausal with no menses for the last 12 months. Preferably, contraceptive measures should be continued until completion of TB treatment, but at least until one month after last dose of IMP, unless she and her partner(s) are sterile (that is, women who have had a bilateral oophorectomy or hysterectomy or have been postmenopausal for at least 12 consecutive months).
Two of the following methods may be used, but only one may be hormonal: tubal ligation, vaginal diaphragm, intrauterine device, condom, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate, partner(s) has had a vasectomy.
9.Male participants must agree to use an adequate method of contraception when not abstaining from sexual intercourse throughout participation in the trial and for 12 weeks after last dose, unless he has had bilateral orchidectomy.
10.A Karnofsky score of at least 60 (requires occasi

Exclusion Criteria

1.Poor general condition where any delay in treatment cannot be tolerated per discretion of Investigator.
2.Treatment with any drug active against MTB within the 3 months prior to Visit 1 (this includes, but is not limited to INH, EMB, RIF, PZA, amikacin, cycloserine, rifabutin, streptomycin, kanamycin, para-aminosalicylic acid, rifapentine, thioacetazone, capreomycin, fluoroquinolone, thioamides, metronidazole).
3.Sputum isolate is resistant to RIF as detected by rapid assay from native sputum
4.A history of allergy to the IMP or related substances.
5.Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the investigator.
6.A history of previous TB.
7.Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease.
8.Laboratory parameters done at, or within 14 days prior to, screening:
¿Serum amino aspartate transferase (AST) and/or serum alanine aminotransferase (ALT) activity >3 times the upper limit of normal
¿Serum total bilirubin level >2.5 times the upper limit of normal
¿Serum creatinine level >2 times the upper limit of normal
¿Complete blood count with hemoglobin level <7.0 g/dL
¿Platelet count <50,000/mm3
¿Serum potassium <3.5 meq/L
9.History, presence, or evidence of a neuropathy or epilepsy.
10.Clinically relevant change s in the ECG such as atrioventricular (AV) block, prolongation of the QRS complex over 120 milliseconds, or of either the QTcF or QTcB interval over 450 milliseconds on the screening ECG.
11.A history of, or current clinically relevant cardiovascular disorder such as myocardial infarction, heart failure, coronary heart disease, hypertension, arrhythmia, or tachyarrhythmia. Family history of sudden death of unknown or cardiac-related cause, or of prolonged QTc interval. Concomitant use of any drug known to prolong QTc interval (including amiodarone, bepridil chloroquine, chlorpromaz

Study & Design

• Study Type: Interventional
• Study Design: Not specified