Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic

NCT04437836 | Completed Phase 1 DMC

• 1 other identifier: TMA2017CDF-1876-HighRif C
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

Tuberculosis in children is a major public health problem and it contributes 10% of the total TB cases worldwide. TB treatment outcomes in children are challenged by insufficient consideration of the relationships between doses administered, concentrations achieved and eventual desirable and undesirable effects (pharmacodynamics) of TB drugs. Rifampicin is a pivotal TB drug and data from adults suggest that a much higher dose of rifampicin (35 mg/kg instead of 10 mg/kg), resulting in much higher rifampicin exposures in plasma, is safe and tolerable and may provide a higher efficacy. The dose needed in children to achieve the same exposure in plasma is unknown.

Conditions

Clinical Trial

Keywords

Tuberculosis, Pharmacokinetics, safety/torelability

Outcome Measures

Primary Outcomes (1)

• Evaluation of high dose rifampicin

  To know the maximum tolerable dose of rifampicin in children aged 1-14 years

  54 months

Secondary Outcomes (2)

• Plasma concentration

  54 months

• Time

  54 months

Study Arms (3)

Control arm

EXPERIMENTAL

Participants will receive standard treatment of rifampicin

Drug: Evaluation of high dose rifampicin in children

First High dose

EXPERIMENTAL

Participants will receive 30mg per kg body weight of rifampicin

Drug: Evaluation of high dose rifampicin in children

Second high dose

EXPERIMENTAL

Particpants will receive 40mg per kg body weight of rifampicin

Drug: Evaluation of high dose rifampicin in children

Interventions

Evaluation of high dose rifampicin in children DRUG

Evaluation of severity of adverse event from grade 1 to 5

Also known as: Safety monitoring

Control arm; First High dose; Second high dose

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 to 14 years with newly diagnosed Tuberculosis

You may not qualify if:

• Children with elevated liver function
• Children allergic to first line anti-TB drugs

Sponsors & Collaborators

• Kilimanjaro Clinical Research Institute: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (4)

Kilimanjaro Clinical Research Institute

Moshi, Kilimanjaro, +255, Tanzania

Location

Hydom Hospital

Babati, Manyara Region, Tanzania

Location

Mt. Meru Hospital

Arusha, Tanzania

Location

Huruma Hospital

Moshi, Tanzania

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Rifampin; Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Enroll children participant and giving them treatment care as well as safety monitoring
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Safety and tolerability study

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 18, 2020
• Study Start: July 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2023
• Last Updated: February 15, 2024

Record last verified: 2023-12

Locations

TA (4)