Trial Outcomes & Findings for Treatment of Latent TB Infection for Jailed Persons (NCT NCT00128206)

NCT ID: NCT00128206

Last Updated: 2020-07-21

Results Overview

Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 364 participants
• Primary outcome timeframe: up to one year
• Results posted on: 2020-07-21

Participant Flow

Inmates in the San Francisco City and County Jail diagnosed with latent tuberculosis infection (LTBI) at jail entry were recruited,consented and enrolled between 11/30/2004 and 9/24/2007.

Of 416 inmates with LTBI who consented to be enrolled, 52 were not randomized because of abnormal liver function tests (20), they were released before they could be assigned to a group (30), or they subsequently changed their mind and refused participation (2).

Participant milestones

Measure	Isoniazid isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin rifampin (600 mg orally) given daily for 4 months
Overall Study STARTED	184	180
Overall Study COMPLETED	47	60
Overall Study NOT COMPLETED	137	120

Reasons for withdrawal

Measure	Isoniazid isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin rifampin (600 mg orally) given daily for 4 months
Overall Study Lost to Follow-up	137	118
Overall Study Adverse Event	0	2

Baseline Characteristics

Treatment of Latent TB Infection for Jailed Persons

Baseline characteristics by cohort

Measure	Isoniazid n=184 Participants isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin n=180 Participants rifampin (600 mg orally) given daily for 4 months	Total n=364 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	183 Participants n=93 Participants	180 Participants n=4 Participants	363 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	30.34 years STANDARD_DEVIATION 9.59 • n=93 Participants	31.51 years STANDARD_DEVIATION 9.57 • n=4 Participants	30.9 years STANDARD_DEVIATION 9.59 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	14 Participants n=4 Participants	25 Participants n=27 Participants
Sex: Female, Male Male	173 Participants n=93 Participants	166 Participants n=4 Participants	339 Participants n=27 Participants
Region of Enrollment United States	184 participants n=93 Participants	180 participants n=4 Participants	364 participants n=27 Participants

PRIMARY outcome

Timeframe: up to one year

Population: The number of participants was determined by power calculations using estimates of toxicity from the literature. The analysis was intention to treat.

Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.

Outcome measures

Measure	Isoniazid n=184 Participants isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin n=180 Participants rifampin (600 mg orally) given daily for 4 months
Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication	6 participants	3 participants

SECONDARY outcome

Timeframe: course of treatment

Outcome measures

Measure	Isoniazid n=184 Participants isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin n=180 Participants rifampin (600 mg orally) given daily for 4 months
Completion of Therapy	47 Participants	60 Participants

SECONDARY outcome

Timeframe: course of treatment

Population: Cost effectiveness data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Isoniazid

Serious events: 11 serious events

Other events: 46 other events

Deaths: 0 deaths

Rifampin

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	Isoniazid n=184 participants at risk isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin n=180 participants at risk rifampin (600 mg orally) given daily for 4 months
Hepatobiliary disorders elevated liver function test	4.3% 8/184 • Number of events 8 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	0.56% 1/180 • Number of events 1 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
Psychiatric disorders suicidal thoughts	0.54% 1/184 • Number of events 1 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	0.56% 1/180 • Number of events 1 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
Surgical and medical procedures hospitalization for ankle surgery	0.54% 1/184 • Number of events 1 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	0.00% 0/180 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
Surgical and medical procedures hospitalization for appendectomy	0.54% 1/184 • Number of events 1 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	0.00% 0/180 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
General disorders allergic reaction	0.00% 0/184 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	0.56% 1/180 • Number of events 1 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.

Other adverse events

Measure	Isoniazid n=184 participants at risk isoniazid (INH) (900 mg orally) given twice weekly for 9 months	Rifampin n=180 participants at risk rifampin (600 mg orally) given daily for 4 months
Gastrointestinal disorders gastrointestinal symptoms	6.5% 12/184 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	5.6% 10/180 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
Skin and subcutaneous tissue disorders skin rash	7.1% 13/184 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	8.9% 16/180 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
Hepatobiliary disorders elevated liver function tests	6.5% 12/184 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	4.4% 8/180 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.
Injury, poisoning and procedural complications injury	4.9% 9/184 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.	6.1% 11/180 • Adverse events were collected during the course of treatment for each participant, until treatment was completed or subject was lost or withdrawn from the study. This was up to 1 year for all participants. Participants had routine blood tests for liver functions and clinical review for symptoms at regular intervals during receipt of the study medication. While they remained in jail, adverse events also were collected for all sick call visits to jail health personnel.

Additional Information

Mary White

University of California, San Francisco

Phone: 415-476-5213

Email: mary.white@nursing.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place