NCT01225640

A Phase 2a, Open-Label, Randomized Study In Treatment-Naive, Sputum Smear Positive Subjects With Drug-Sensitive Pulmonary Tuberculosis To Assess Early Bactericidal Activity (EBA) And Whole Blood Activity (WBA) Of PNU-100480 (PF-02341272)

Completed Phase 2 Last updated 14 December 2015

What this trial tests

Phase 2 trial testing PNU-100480 in Tuberculosis in 59 participants. Completed in 1 December 2011.

Timeline

1 August 2011

Primary endpoint
1 December 2011

1 December 2011

Quick facts

Lead sponsor	Sequella, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	1 August 2011
Primary completion	1 December 2011
Estimated completion	1 December 2011
Sites	2 locations across South Africa

Drugs / interventions tested

• PNU-100480 — full drug profile →
• PNU-100480 — full drug profile →
• RHZE — full drug profile →

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Sequella, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary endpoint is rate of change in sputum log CFU/mL count (EBA) from Days 0-2.
  Time frame: Days 0-2

Sponsor's own description

PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days to treatment-naive patients with drug-sensitive pulmonary tuberculosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New agents for the treatment of drug-resistant Mycobacterium tuberculosis.
   Hoagland DT, Liu J, Lee RB, Lee RE. · · 2016 · cited 218× · PMID 27151308 · DOI 10.1016/j.addr.2016.04.026
2. Antibiotics in the clinical pipeline in October 2019.
   Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
3. Antibiotics in the clinical pipeline as of December 2022.
   Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
4. Mycobactericidal activity of sutezolid (PNU-100480) in sputum (EBA) and blood (WBA) of patients with pulmonary tuberculosis.
   Wallis RS, Dawson R, Friedrich SO, Venter A, et al · · 2014 · cited 122× · PMID 24732289 · DOI 10.1371/journal.pone.0094462
5. Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines.
   Schito M, Migliori GB, Fletcher HA, McNerney R, et al · · 2015 · cited 77× · PMID 26409271 · DOI 10.1093/cid/civ609
6. New anti-tuberculosis drugs and regimens: 2015 update.
   D'Ambrosio L, Centis R, Sotgiu G, Pontali E, et al · · 2015 · cited 42× · PMID 27730131 · DOI 10.1183/23120541.00010-2015
7. New Drugs for the Treatment of Tuberculosis.
   Ignatius EH, Dooley KE. · · 2019 · cited 39× · PMID 31731986 · DOI 10.1016/j.ccm.2019.08.001
8. Recent advances in tuberculosis: New drugs and treatment regimens.
   Sloan DJ, Davies GR, Khoo SH. · · 2013 · cited 31× · PMID 24683386 · DOI 10.2174/1573398x113099990017