HRZE Fasted/Fed in Newly Diagnosed TB (FASTFOOD)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 2

Conditions: Tuberculosis

Treatments: Drug: intravenous administration of 1st line TB drugs, day 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02121314

UGM-RuG-UMCG-TB-001

Details and patient eligibility

About

WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug concentrations are too low; on the other hand: if this is not tolerated, drugs could also be taken with food.

Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage of lower drug blood concentrations over time? How exactly do the drug concentrations over time (pharmacokinetics) compare between fasting and fed conditions, especially in the early stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB drugs?

Full description

To evaluate the influence of concomitant food ingestion on the pharmacokinetics of HRZE in newly diagnosed TB patients To evaluate the influence of early disease on the PK parameters of HRZE in TB patients To compare the pharmacokinetics of HRZE in the early stage of disease with the pharmacokinetics of HRZE in more stable condition in newly diagnosed TB patients To evaluate adverse events of HRZE in TB patients

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with TB who are starting with HRZE therapy
• Age > 18 years old
• Written informed consent

Exclusion criteria

• Use of antacids, which cannot be discontinued for study days
• Active, unstable hepatic disease (with jaundice, HRZ)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Fasting-Fed

Active Comparator group

Description:

blood sampling on 3 consecutive days; by randomization, drug treatment as follows: day 1, HRZE as iv therapy; on day 2, HRZE as oral therapy in fasting condition (2 hours before meals); and on day 3 HRZE as oral therapy in fed condition (after meals).

Treatment:

Drug: intravenous administration of 1st line TB drugs, day 1

Fed-Fasting

Active Comparator group

Description:

blood sampling on 3 consecutive days; by randomization, drug treatment as follows: day 1, HRZE therapy as iv therapy; day 2, HRZE as oral therapy in fed condition, and on day 3, HRZE as oral therapy in fasting condition

Treatment:

Drug: intravenous administration of 1st line TB drugs, day 1