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Completed

NCT Number: NCT01698476

Immune Reconstitution in Tuberculosis Disease

The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.

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Key information

Conditions

Pulmonary Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine

Addis Ababa, Lideta sub city, Ethiopia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

HIV negative patients, adult patients >18 years who has not started anti-TB therapy.

Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment).

Exclusion criteria

Patients who have already started treatment with anti-TB drugs for more that 5 days.

HIV-positive patients.

History of anti-TB treatment in the past 2 years.

Local extra-pulmonary TB in the absence of lung manifestations.

Hypercalcaemia (serum calcium > 3 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

Treatment and study plan

vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)

Drug

Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.

Placebo tablets

Drug

Primary outcomes

  1. Composite clinical TB score

    Time frame: 0 (baseline) compared to 8 weeks.

    A previously described composite clinical TB score will be used to monitor the efficacy of vitamin D and phenylbutyrate treatment among TB patients on standard chemotherapy. The numerical TB score will include self-reported clinical symptoms (cough, night sweats and chest pain) as well as different parameters determined upon clinical examination anemia, haemoptysis, dyspnoea, tachycardia, positive finding at lung auscultation, fever, low body mass index (BMI) and low mid upper arm circumference (MUAC). The TB score will be determined at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at time point 8 weeks compared to baseline (time point 0).

Secondary outcomes

  1. Clinical secondary endpoints

    Time frame: 0-4, 8, 16 and 24 weeks

    Clinical composite TB score (0, 4, 16, 24 weeks).

    Modified clinical composite TB score (0, 4, 8, 16, 24 weeks).

    Chest X-ray (0, 4, 8, 16, 24 weeks).

    Time to sputum- and/or TB culture conversion (0, 1, 2, 3, 4, 8 weeks).

  2. Laboratory secondary endpoints

    Time frame: 0, 4, 8, 16, 24 weeks

    Peripheral CD4/CD8 T cell counts.

    Antibodies in lymphocytes secertions (ALS) (S Ashenafi, Thorax, 2012).

    Quantiferon-in-tube TB-gold (QFT).

    Plasma levels of vitamin D, LL-37 and also cytokine/chemokine profiles.

    Functional studies of immune cells (PBMCs).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Addis Ababa University
  • Armauer Hansen Research Institute, Ethiopia

Registry information

Official study title

Immune Reconstitution in Tuberculosis Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate

Acronym: IRETB

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2012
Registry last updated
Feb 5, 2016

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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