Shorter treatment for minimal TB in children

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201505001141379
• Date of registration: 14/05/2015
• Prospective Registration: Yes
• Primary sponsor: University College London
• Public title: Shorter treatment for minimal TB in children
• Scientific title: A randomised trial of therapy shortening for minimal tuberculosis with new WHO-recommended doses/fixed-dose-combination drugs in African and Indian HIV+ and HIV- children
• Date of first enrolment: 31/07/2015
• Target sample size: 1200
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1141
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a web-based system,Allocation was determined by someone situated elsewhere
• Phase: Not Applicable

Countries of recruitment

India, South Africa, Uganda, Zambia

Contacts

• Name: Anna Turkova
• Affiliation: Trial Physician

• Name: Jacqueline Teera
• Affiliation: Trial Manager

Key inclusion & exclusion criteria

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

Age minimum: 0 Year(s)
Age maximum: 16 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
Paediatrics

Tuberculosis

Paediatrics

Intervention(s)

4-month regimen

6 month regimen

Primary Outcome(s)

TB disease-free survival 72 weeks post-randomisatio will be determined by the ERC and categorised as: favourable, unfavourable (including death, reinfection or relapse) or not assessable (e.g. lost to follow-up)

Secondary Outcome(s)

5. adherence and Acceptability

6. Bacterial infections

4. Suppressed HIV viral load at 24 and 48 weeks in HIV-infected children

3. Relapse/re-infection-free survival including only cases adjudicated to be TB by the independent ERC

1. Mortality

2. Adverse drug reactions within 30 days of completing treatment

Secondary ID(s)

ISRCTN63579542

Source(s) of Monetary Support

Joint Global Health Trials Scheme of MRC UK/DfID/Wellcome Trust

Ethics review

Status: Approved
Approval date: 22/05/2014
Contact:

UCL Research Ethics Committee