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Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses

Information source: Statens Serum Institut
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis

Intervention: C-Tb (Biological); Tuberculin PPD RT 23 SSI (Biological); C-Tb / Tuberculin PPD RT 23 SSI (Biological)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Statens Serum Institut

Official(s) and/or principal investigator(s):
Pernille N Tingskov, BN, RN, Study Director, Affiliation: Statens Serum Institut
Keertan Dheda, MD, Prof, Principal Investigator, Affiliation: UCT Lung Institute, University of Cape Town

Summary

A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or induration at the injection site, while a negative test will leave no reactions. The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.

Clinical Details

Official title: A Phase II/III Trial Investigating if Concomitant Injections of the Diagnostic Agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI Affect the Induration Responses in Combination With a Safety Assessment of C-Tb

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome:

To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives)

To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients

Secondary outcome:

To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test

To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test

To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests

Detailed description: The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial investigating if concomitant injections of the diagnostic agents C-Tb and 2 T. U Tuberculin PPD RT 23 SSI affect the induration responses in combination with a safety assessment of C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated to 3 trial groups.

- A within group paired comparison of 0. 1 ╬╝g/0. 1 mL C-Tb and PPD RT 23 in 150 TB

patients. The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a randomisation scheme.

- A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT

or LEFT forearm.

- A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised

to either RIGHT or LEFT forearm.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria (HIV Negative patients):

- Has signed an informed consent

- Aged 18 to 65 years

- Has been diagnosed with active pulmonary TB:

1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis

- Is HIV negative confirmed by 2 two rapid tests

- Is willing and likely to comply with the trial procedures

- Is prepared to grant authorized persons access to their medical record

Inclusion Criteria (HIV Positive patients):

- Has signed an informed consent

- Aged 18-65 years

- Has been diagnosed with active pulmonary TB:

1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis

- Is HIV positive confirmed by:

1. 2 positive rapid tests or 2. 1 positive rapid tests and an additional confirmatory ELISA

- A CD4 count has been performed

- Is willing and likely to comply with the trial procedures

- Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

- Has been in treatment for TB for more than 2 weeks

- Has a known MDR/XDR-TB

- Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion

(e. g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine

- Has been tuberculin (TST) tested < 12 months prior to the day of inclusion

- Is pregnant, breastfeeding or intending to get pregnant

- Is a female of child bearing potential not willing to use effective barrier

(including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period

- Has an active disease affecting the lymphoid organs except for HIV (e. g., Hodgkin's

disease, lymphoma, leukaemia, sarcoidosis)

- Has a current skin condition which interferes with the reading of the skin tests e. g.

tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites

- Has a condition where blood drawings pose more than minimal risk for the patient,

such as haemophilia, other coagulation disorders, or significantly impaired venous access

- Currently participating in another clinical trial with an investigational or non

investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing

- Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10

antigens

- Has a condition which in the opinion of the investigator is not suitable for

participation in the study

Locations and Contacts

TASK, M2, Karl Bremer Hospital,, Cape Town 7530, South Africa

Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town 7530, South Africa

UCT Lung Institute, Cape Town 7925, South Africa

Primecure Medicentre, Port Elizabeth 6014, South Africa

Setshaba Research Centre, Pretoria 0152, South Africa

Synexus Stanza Bopape Clinic, Pretoria 0122, South Africa

Be Part Yoluntu Centre, Paarl, Western Cape 7626, South Africa

Additional Information

Starting date: October 2013
Last updated: April 16, 2015

Page last updated: August 23, 2015

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