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Completed

NCT Number: NCT02121314

HRZE Fasted/Fed in Newly Diagnosed TB

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?

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Fasting Feeding Behavior Genetic Diseases, Inborn Gram-Positive Bacterial Infections Hypoalphalipoproteinemias Hypolipoproteinemias Infections Lecithin Cholesterol Acyltransferase Deficiency Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Mycobacterium Infections Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sardjito Central Hospital

Yogyakarta, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intravenous administration of 1st line TB drugs, day 1

Drug

TB drugs IV on day 1 for calculation of bioavailability while fasting or fed

Primary outcomes

  1. pharmacokinetics

    Time frame: 3 days - week 1 and week 8

    pharmacokinetics (AUC0-8, Cmax, and Tmax); comparison between TB patients who take HRZE concomitant with food and TB patients who take HRZE concomitant without food, weeks 1 and 8 of treatment

  2. pharmacokinetics (AUC0-8, Cmax, and Tmax) of HRZE

    Time frame: 11 time points, 3 consecutive days - wk 1 & 8

    PK curves from venous blood specimens sampled from indwelling venous catheter

Secondary outcomes

  1. To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not

    Time frame: week 1 - week 8

    tolerance - acceptance; vomiting, refusal

Other outcomes

  1. confounding factors for primary and secondary outcomes

    Time frame: weeks 1 and 8

    Parameters which may influence the pharmacokinetics of HRZE will be measured at start and end of the study.

    • BMI, i.e. body weight and length
    • age
    • gender
    • ethnicity
    • co-morbidity, for instance HIV/AIDS, diabetes (only at start)
    • co-medication: especially HIV medication, prednisolone (may lower INH concentration), antacids (may lower absorption of HRE concentration)
    • chemistry: liver function, renal function, hemoglobulin, albumin, bilirubin
    • pharmacogenetics

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Gadjah Mada University
  • University of Groningen

Registry information

Official study title

The Influence of Fasting and Food on the Pharmacokinetics of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol in Newly Diagnosed TB Patients

Acronym: FASTFOOD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2014
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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