Shorter treatment for minimal TB in childre

Not Applicable

Not yet recruiting

• Conditions: Tuberculosis; Paediatrics

• Registration Number: PACTR201505001141379
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Age 0-16 years
2. Weight ¿ 3kg.
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 (minimal 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

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, osteoarticular TB,abdominal TB, congenital TB
4. Pre-extisting 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 contract with MDR, pre-XDR or XDR adult source case
7. Proven drug resistance in the child (R resistance with or without H resistance), H mono-resistance allowed
8. Severely sick
9. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified