drugset / Trial / NCT02623556
Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
Phase 3
Completed
1090 enrolled
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Air Force Military Medical University, China · collabAnhui Provincial Hospital · collabBeijing Chest Hospital · collabFirst Affiliated Hospital of Chongqing Medical University · collabFuzhou Pulmonary Hospital of Fujian · collabProswell Medical Corporation · collabShanghai Public Health Clinical Center · collabShenzhen Third People's Hospital · collabTianjin Haihe Hospital · collabWuhan Institute for Tuberculosis Control · collabWuxi Hospital for Infectious Diseases · collabZhenjiang Third People's Hospital · collab
RandomizedParallel-groupDouble-blindDiagnostic
Summary
720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung disease and suspected TB patients who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events.
Timeline
- Start
- 2015-12
- Primary completion
- 2018-03
- Completion
- 2018-03
Publications
- Background van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000.
- Background Ravn P, Munk ME, Andersen AB, Lundgren B, Lundgren JD, Nielsen LN, Kok-Jensen A, Andersen P, Weldingh K. Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis. Clin Diagn Lab Immunol. 2005 Apr;12(4):491-6. doi: 10.1128/CDLI.12.4.491-496.2005.
- Background Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x.
- Background Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978.
- Background Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ESAT6-CFP10 | Protein / enzyme biologic | 10 ug/ml | Other |
| Subject | TB-PPD | Diagnostic / imaging agent | — | Other |