Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-14

Study Completion Date

2017-12-28

Brief Summary

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The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.

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Detailed Description

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This trial will investigate the pharmacokinetics (PK) and safety of delamanid administered for 10 days to pediatric patients aged birth to 17 years who are also on therapy with an optimized background regimen. The purpose of the trial is to determine which dose in pediatric MDR-TB patients will result in delamanid plasma exposure similar to efficacious plasma exposure in adult MDR-TB patients. This is an age de-escalation trial in four groups:

Group 1: 12 to 17 years (100 mg BID; n=6) Group 2: 6 to 11 years (50 mg BID; n=6) Group 3: 3 to 5 years (25 mg BID; n=12) Group 4: Birth to 2 years (Dose based on patient's body weight, n=12)

* Patients \> 10 kg will receive 10 mg BID
* Patients \> 8 kg and ≤ 10 kg will receive 5 mg BID
* Patient ≤ to 8 kg will receive 5 mg QD

Conditions

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Multidrug Resistant Tuberculosis Pediatric

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: 12 to 17 years of age

Group 1: 100 mg Delamanid BID for 10 days + OBR

Group Type EXPERIMENTAL

100 mg Delamanid

Intervention Type DRUG

100 mg Delamanid BID for 10 days

Optimized Background Regimen

Intervention Type DRUG

Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country

Group 2: 6 to 11 years of age

50 mg Delamanid BID for 10 days + OBR

Group Type EXPERIMENTAL

50 mg Delamanid

Intervention Type DRUG

50 mg Delamanid BID for 10 days

Optimized Background Regimen

Intervention Type DRUG

Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country

Group 3: 3 to 5 years of age

25 mg Pediatric Formulation Delamanid BID for 10 days + OBR

Group Type EXPERIMENTAL

25 mg Pediatric Formulation Delamanid

Intervention Type DRUG

25 mg Pediatric Formulation Delamanid BID for 10 days

Optimized Background Regimen

Intervention Type DRUG

Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country

Group 4: Birth to 2 years of age

Delamanid Pediatric Formulation (DPF) for 10 days + OBR. DPF dose based on patient's body weight during baseline visit:

* Patient's \> 10 kg will receive DPF 10 mg BID + OBR
* Patient's \> 8 kg and ≤ 10 kg will receive DPF 5 mg BID + OBR
* Patients ≤ 8 kg will receive DPF 5 mg QD + OBR

Group Type EXPERIMENTAL

10 mg Delamanid Pediatric Formulation

Intervention Type DRUG

Patients \> 10 kg will receive DPF 10 mg BID for 10 days

5 mg Delamanid Pediatric Formulation

Intervention Type DRUG

Patients \> 8 kg and ≤ 10 kg will receive DPF 5 mg BID for 10 days

Patients ≤ 8 kg will receive DPF 5 mg QD for 10 days

Optimized Background Regimen

Intervention Type DRUG

Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country

Interventions

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100 mg Delamanid

100 mg Delamanid BID for 10 days

Intervention Type DRUG

50 mg Delamanid

50 mg Delamanid BID for 10 days

Intervention Type DRUG

25 mg Pediatric Formulation Delamanid

25 mg Pediatric Formulation Delamanid BID for 10 days

Intervention Type DRUG

10 mg Delamanid Pediatric Formulation

Patients \> 10 kg will receive DPF 10 mg BID for 10 days

Intervention Type DRUG

5 mg Delamanid Pediatric Formulation

Patients \> 8 kg and ≤ 10 kg will receive DPF 5 mg BID for 10 days

Patients ≤ 8 kg will receive DPF 5 mg QD for 10 days

Intervention Type DRUG

Optimized Background Regimen

Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country

Intervention Type DRUG

Other Intervention Names

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OPC-67683 OPC-67683 DPF DPF DPF OBR

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of MDR-TB OR
* Presumptive diagnosis of MDR-TB including one of the following:

* Clinical specimen suggestive of TB
* Persistent cough lasting \> 2 weeks
* Fever, weight loss, and failure to thrive
* Findings on recent chest radiograph (prior to Visit 1) consistent with TB AND
* Household contact of a person with known MDR-TB or a person who died while appropriately taking drugs for sensitive TB OR
* On first-line TB treatment but with no clinical improvement
* Negative urine pregnancy test for female patients who have reached menarche
* Written informed consent/assent

Exclusion Criteria

* Laboratory evidence of active hepatitis B or C
* Children with body weight \< 5.5 kg
* For patients with HIV co-infection, CD4 cell count ≤ 1000/mm3 for children 1-5 years old, and ≤ 1500/mm3 for children less than 1 year old
* History of allergy to metronidazole and any disease or condition in which metronidazole is required
* Use of amiodarone within 12 months or use of other predefined antiarrhythmic medications within 30 days prior to first dose of delamanid
* Serious concomitant conditions
* Preexisting cardiac conditions
* Abnormalities in Screening ECG (including AV block, BBB or hemi-block, QRS prolongation \> 120 msec, or QTcF \> 450 msec in both males and females)
* Concomitant condition such as renal impairment characterized by serum creatinine levels \>1.5 mg/dL, hepatic impairment (ALT or AST \> 3x ULN), or hyperbilirubinemia characterized by total bilirubin \> 2x ULN
* Current diagnosis of severe malnutrition or kwashiorkor
* Positive urine drug screen (Groups 1 and 2 only)
* Rifampicin and/or moxifloxacin within 1 week prior to the first dose of delamanid and/or any prior or concurrent use of bedaquiline
* Lansky Play Performance Score \< 50 (not applicable for children \< 1 year old) or Karnofsky Score \< 50
* Administered an IMP within 1 month prior to Visit 1
* Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the information consent form (Groups 1 and 2 only)

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No