Clinical trial of treatment shortening for minimal tuberculosis in children.

Phase 3

Recruiting

Conditions: Minimal Tuberculosis in Children.

Registration Number: CTRI/2017/07/009119

Lead Sponsor: University College London

Brief Summary: This studyis a randomized, open label, parallel arm, phase III clinical trial of therapy shorteningfor minimal tuberculosis with new WHO-recommended doses/ fixed-dose-combinationdrugs in African and Indian HIV+ and HIV- children below 16 years of age. Theprimary outcome measures will be unfavorableoutcomes: TB treatment failure, relapse (or re-infection) or death and adverseevents. The secondary outcome measures will be mortality, adverse drug reactionsup to one month of completing treatment, suppressed HIV viral load at specifiedtime points in HIV infected children.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 1200

Inclusion Criteria

Age 0-16 years 2.
Weight â‰¥ 3kg.
This has been expanded to include children weighing between 3 and 4kg; a detailed PK study of individual drugs in infants is ongoing and data using the new FDC from this study will ensure that use of this new formulation is also studied in these smallest infants.
Clinician has decided to treat with standard first-line regimen (intensive phase of 4 drugs or 3 drugs as per local practice) 4.
Symptomatic but non-severe TB including: a.
extrathoracic lymph node TB; intra-thoracic uncomplicated (hilar) lymph node TB b.
minimal or no parenchymal abnormality on CXR c.
smear gastric aspirate/other respiratory sample (minimum 2 samples) negative Note: GeneXpert may be positive or negative; culture of respiratory sample may be positive or negative; lymph node aspirate may be smear/culture/GeneXpert positive or negative) 5.
Not previously treated for TB or successfully treated for TB > 2 years since last completed treatment 6.
Known HIV status; HIV-infected or HIV-uninfected 7.
Willing and likely to adhere to 72 weeks follow up 8.
Informed written consent from the parent/legal caregiver(s) and assent in children, as per local Ethics Committee guidance 9.
Home address accessible for visiting and intending to remain within the recruitment area for follow up 10.
Since participants will all be under legal age of independent consent, a parent or legal guardian must be willing and able to provide informed consent.
If the subject is of appropriate age, she/he will also be asked to give assent if developmentally appropriate and clinically possible.
Participant can comply with the protocol requirements in the opinion of the site investigator.

Exclusion Criteria

1.Smear-positive respiratory sample TB (note: smear-positive peripheral lymph node sample is allowed) 2.
Premature (<37 weeks) and aged under 3 months 3.
Miliary TB, spinal TB, TB meningitis, osteo articular TB, abdominal TB, congenital TB 4.
Pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. liver or kidney disease, peripheral neuropathy, cavitation 5.
Any known contraindication to taking anti-TB drugs 6.
Known contact with drug resistant adult source case (including mono-resistant TB) 7.
Known drug resistance in the child 8.
Severely sick 9.
Pregnancy 10.
A clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition (outside of TB), which, in the opinion of the site investigator, would prevent appropriate participation in the trial, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TB disease free survival 72 weeks post randomisation will be determined by the ERC and categorised as:	72 weeks post randomisation
1. Favourable	72 weeks post randomisation
2.Unfavourable (including death, reinfection or relapse) or	72 weeks post randomisation
3. Not assessable (e.g. lost to follow-up)	72 weeks post randomisation

Secondary Outcome Measures

Name	Time	Method
1.Mortality	2.Adverse drug reactions within 30 days of completing treatment

Trial Locations

Locations (4): B.J. Government Medical College and Sassoon General Hospital
🇮🇳
Pune, MAHARASHTRA, India
Madras Medical College
🇮🇳
Chennai, TAMIL NADU, India
National Institute for Research in Tuberculosis
🇮🇳
Chennai, TAMIL NADU, India
Stanley Medical College
🇮🇳
Chennai, TAMIL NADU, India
B.J. Government Medical College and Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Arathi Kiniker
Principal investigator
9850039063
aarti.kinikar63@gmail.com