Clinical trial of treatment shortening for minimal tuberculosis in children.

Phase 3

• Conditions: Health Condition 1: null- Minimal Tuberculosis in Children.

• Registration Number: CTRI/2017/07/009119
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age 0-16 years

2. Weight >= 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.

3. 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.

11. 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