Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06253715 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Shortened Regimen for Drug-susceptible TB in Children

Study acronym: SMILE-TB
StatusRecruiting
PhasePhase 3
Started2025-01-15
View on ClinicalTrials.gov ↗

Amendment history

2026-07-22
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 9 sites
2026-07-17
Study Status, Contacts/Locations v16
Study sitesdetails revised at 1 of 9 sites
2026-05-28
Study Status, Contacts/Locations v15
Study sitesdetails revised at 3 of 9 sites
2026-04-01
Study Status v14
Primary completion pushed: 2027-07-31 → 2027-09-30
Completion pushed: 2027-07-31 → 2027-09-30
2026-03-19
Study Status, Contacts/Locations v13
Primary completion date2027-09-30→2027-07-31
Completion date2027-09-30→2027-07-31
Study sitesdetails revised at 1 of 9 sites
Show 12 earlier versions
2025-11-18
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 9 sites
2025-10-07
Study Status, Contacts/Locations v11
Study sites7→9
2025-05-12
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 7 of 7 sites
2025-02-06
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 7 of 7 sites
2025-01-16
Study Status v8
Start dateestimated 2025-01-17→confirmed 2025-01-15
2025-01-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start date2024-12-13→2025-01-17
Study sitesdetails revised at 7 of 7 sites
2024-12-03
Study Status v6
Start date2024-11-27→2024-12-13
2024-11-26
Study Status, Contacts/Locations v5
Study sites5→7
2024-11-08
Study Status v4
Start date2024-11-15→2024-11-27
2024-10-15
Study Status v3
Start date2024-10-15→2024-11-15
2024-09-23
Study Status v2
Start date2024-09-30→2024-10-15
2024-06-10
Study Status, Outcome Measures, IPDSharing v1
Secondary endpoints14 entries, revised
Cost- effectiveness ofas assessed by the HPZMincremental regimencost-effective comparedratio with the HRZ(EICER) regimen
2024-02-02
Original filing
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.
Trial Details
NCT Number NCT06253715
Lead Sponsor Johns Hopkins University
Collaborators: United States Agency for International Development (USAID)
Conditions Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium Tuberculosis
Enrollment 860 participants
Start Date 2025-01-15
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-24