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Tuberculosis, PulmonaryPhase 2SQ109EBANCT01218217

Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB

A Phase 2 study testing SQ109 and Rifampicin in people with Tuberculosis, Pulmonary, run by Michael Hoelscher at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SQ109 was developed with the aim of shortening TB treatment and providing new drugs for resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable safety profile in first-in-man studies. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Tuberculosis, Pulmonary
What is being tested?
SQ109 and Rifampicin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesSouth Africa
Study dates
Nov 2010to May 2012
Phase
Phase 2
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
  • Be eighteen (18) to 64 (inclusive) years of age.
  • Have a body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
  • Have newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
  • Have a chest X-ray which, in the opinion of the Investigator, is compatible with TB.
  • Is sputum positive on direct microscopy for acid-fast bacilli (at least 1+ on the IUATLD/WHO scale (Appendix 3).
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  • Is able to produce an adequate spot sputum sample, indicating an overnight sputum volume of at least 10 mL.
  • 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.
  • 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.
  • A Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs, see Appendix 5)

Who cannot join

  • Poor general condition where any delay in treatment cannot be tolerated per discretion of Investigator.
  • 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).
  • Sputum isolate is resistant to RIF as detected by rapid assay from native sputum
  • A history of allergy to the IMP or related substances.
  • Clinically significant evidence of extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the investigator.
  • A history of previous TB.
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  • Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease.
  • 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
  • History, presence, or evidence of a neuropathy or epilepsy.
  • 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.
  • 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, chlorpromazine, cisapride, cisapride, clarithromycin, disopyramide dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, lumefantrine, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine).
  • Diabetics using insulin.
  • Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
  • Any disease or condition in which the use of the standard TB drugs or any of their components is contraindicated, including but not limited to allergy to any TB drug, their components or to the IMPs.
  • Any disease or condition in which any of the medicinal products listed in the section pertaining to prohibited medication (see 4.10.4) is used.
  • Known or suspected, current or history of within the past 2 years, alcohol or drug abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient. Opiates prescribed for cough relief are not counted as drug abuse.
  • Prior administration of SQ109.
  • Is pregnant, breast-feeding, or planning to conceive or father a child within one month of cessation of treatment.
  • Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes (including xenobiotics, quinidine, tyramine, ketoconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan). Exceptions may be made for subjects that have received 3 days or less of one of these drugs or substances, if there has been a wash-out period equivalent to at least 5 half-lives of that drug or substance.
  • Use of any therapeutic agents within 30 days prior to dosing known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine).
  • Use of systemic glucocorticoids within three months prior to dosing.
  • HIV infection with helper/inducer T lymphocyte (CD4 cell) count of 250 10-6/L.
  • Receiving antiretroviral therapy (ART).

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • TASK Applied Sciences

    Cape Town

  • University of Cape Town

    Cape Town

Other trials in South Africa

About this study

Official title: A Phase 2A Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of SQ109 in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

SQ109 was developed with the aim of shortening TB treatment and providing new drugs for resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable safety profile in first-in-man studies. The objective of this study is to evaluate the extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB.

Being tested
SQ109, Rifampicin
Keywords
TB, Tuberculosis, EBA, Pulmonary, Early Bactericidal Activity
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis

What participants receive

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

  • SQ109Drug

    SQ109 150 mg tablet

  • RifampicinDrug

    Rifampicin 150 mg capsules

Study groups in NCT01218217
Study groupRoleWhat they receive
SQ109 75 mgExperimental75 mg SQ109 monotherapy daily
Receives: Drug: SQ109
SQ109 150 mgExperimental150 mg SQ109 daily
Receives: Drug: SQ109
SQ109 300 mgExperimental300 mg SQ109 daily
Receives: Drug: SQ109
SQ109 150 mg + RIFExperimental150 mg SQ109 + RIF standard dose daily
Receives: Drug: SQ109; Drug: Rifampicin
SQ109 300 mg + RIFExperimental300 mg SQ109 + RIF standard dose daily
Receives: Drug: SQ109; Drug: Rifampicin
RIF MonoActive comparatorStandard dose Rifampicin monotherapy daily
Receives: Drug: Rifampicin

What is being measured

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

  1. The extended early bactericidal activity (EBA)of daily 75 mg, 150 mg, and 300 mg SQ109, and of daily 150 mg or 300 mg SQ109 with daily RIF standard dose in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB.

    Measured: Daily during first two weeks

Secondary outcomes (5)

  1. The standard EBA (EBA 0-2) of each treatment group, as determined by the rate of change of log Colony Forming Units (logCFU) in sputum over the period Day 0-2 (linear, bi-linear or non-linear regression of logCFU over time).

    Measured: Day 0 - Day 2

  2. Extended EBA (EBA 2-14) of each treatment group, as determined by the rate of change of logCFU in sputum over the periods Day 2-14 (linear, bi-linear or non-linear regression of logCFU over time).

    Measured: Days 2-14

  3. The change in time to positivity (TTP) in the Mycobacterium Growth Indicator Tube (Bactec MGIT 960 system).

    Measured: Days 0-14

  4. Pharmacokinetics

    Measured: Days 1,2,7,8,14,15

  5. Proportion of subjects with serious adverse events and proportion of subjects who discontinue due to an adverse event in each experimental arm.

    These will be presented as descriptive analyses, and no inferential tests will be carried out.

    Measured: Entire study period

Timeline

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

  1. First posted11 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionSep 2011
  4. Study completionMay 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218217
Sponsor's protocol ID
LMU-IMPH-SQ109-01
Acronym
SQ109EBA
Status last verified
Jan 2013
First submitted
8 Oct 2010
Last updated
14 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SQ109 and Rifampicin in people with Tuberculosis, Pulmonary, run by Michael Hoelscher at 2 sites in South Africa.

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 11 inclusion and 29 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: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The extended early bactericidal activity (EBA)of daily 75 mg, 150 mg, and 300 mg SQ109, and of daily 150 mg or 300 mg SQ109 with daily RIF standard dose in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB. (time frame: Daily during first two weeks). 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 NCT01218217.

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 14 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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