Open clinical trial phase IIa to study the isoniazid suspension absoption for the tuberculous infection treatment in patients under the age of 6

Open clinical trial phase IIa to study the isoniazid suspension absoption of 10mg/ml for the tuberculosis infection treatment in patients under the age of 6

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002000-31-ES

Enrollment

Registered

2016-08-05

Start date

2016-09-21

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tuberculosis infection in patients under the age of 6

Interventions

Trade Name: Isoniazid Syrup USP Pharmaceutical Form: Syrup INN or Proposed INN: ISONIAZID CAS Number: 54-85-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients between > or = 29 days and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Any infection disease, hepatic or renal of base susceptible to alter the isoniazid metabolism (i.e. VIH infection or hepatotropos virus). - Treatment necesity with other drugs liable to modify the isoniazid metabolism (i.e. antiepileptic, antiretroviral, etc.). - Study basal hepatic function alteration, defined with a elevation in the alanine aminotransferases levels two or three times the normality higher level, it is 40 UI/L per 2: values > or 80UI/L.

Design outcomes

Primary

Measure	Time frame
Main Objective: Isoniazid maximum concentration description in serum of patients under the age of 6 in treatment with a unique oral daily dose of study drug 10mg/Kg for primary o secundary chemoprophylaxis of latent tuberculosis infection or tuberculosis disease treatment.;Secondary Objective: - Describe other pharmacokinetic parameters (are under the curve, time to the maximum concentration), after the isoniazid administration in a unique oral daily dose of 10mg/kg in the study population and the equivalence between the two groups of patients: baby from 1 month to 2 years; and preschoolers, from 2 to 6 years of life. - Study the influence of other factors in the pharmacokinetics parameters studied: gender, nutritional state, treatment indication (primary or secundary chemoprophylaxis of the latent tuberculosis infection or tuberculosis disease treatment), acetylator NAT2 genotype and coadministration of other tuberculostatic drugs. - Treatment security.;Primary end point(s): Maximum concentration (Cmax) in serum of isoniazid (quantitative variable, in mg/L);Timepoint(s) of evaluation of this end point: Patients in monoterapy:1 or 2 hours post-dosis, 3 or 4 hours post-dose, 6 or 8 hours post-dosis. In combined treatment with other drugs anti-tuberculose : Pre-dose, 1 or 2 hours post-dose, 3 or 4 hours post-dose, 6 or 8 hours post-dose and 10 or 12 hours post-dose	—

Measure

Time frame

Main Objective: Isoniazid maximum concentration description in serum of patients under the age of 6 in treatment with a unique oral daily dose of study drug 10mg/Kg for primary o secundary chemoprophylaxis of latent tuberculosis infection or tuberculosis disease treatment.;Secondary Objective: - Describe other pharmacokinetic parameters (are under the curve, time to the maximum concentration), after the isoniazid administration in a unique oral daily dose of 10mg/kg in the study population and the equivalence between the two groups of patients: baby from 1 month to 2 years; and preschoolers, from 2 to 6 years of life. - Study the influence of other factors in the pharmacokinetics parameters studied: gender, nutritional state, treatment indication (primary or secundary chemoprophylaxis of the latent tuberculosis infection or tuberculosis disease treatment), acetylator NAT2 genotype and coadministration of other tuberculostatic drugs. - Treatment security.;Primary end point(s): Maximum concentration (Cmax) in serum of isoniazid (quantitative variable, in mg/L);Timepoint(s) of evaluation of this end point: Patients in monoterapy:1 or 2 hours post-dosis, 3 or 4 hours post-dose, 6 or 8 hours post-dosis. In combined treatment with other drugs anti-tuberculose : Pre-dose, 1 or 2 hours post-dose, 3 or 4 hours post-dose, 6 or 8 hours post-dose and 10 or 12 hours post-dose

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Secondary

Measure	Time frame
Secondary end point(s): - Time to the maximum concentration in serum of isoniazid (quantitative variable, in hours). - Minimum concentration in serum of isoniazid (quantitative variable, in mg/L). - Area under the curve of isoniazid concentration in serum (quantitative variable, in mg h/L). From time 0 to 6h (AUC6) and time from 0 to 24h (AUC24) in a posological interval. - Plasmatic clearance of isoniazid (quantitative variable, in L/h) - Apparent distribution volume of isoniazid ( quantitative variable, in liters). - Acetylator genotype (qualitative variable): quick homozygote acetylator, slow homozygote acetylator, or intermediate acetylator. - In patients with tuberculosis disease: disease type (intrathoracic or extratoracic; dichotomic variable) and concomitant treatments with other tuberculostatic drugs (yes/no; dichotomic variable). - Malnutrition (yes/no, dichotomic variable). Defined with weight and/or body mass index lower than -2DS according to the Spanish standar. - Gender, gestational state and weight in the moment of birth, indication about the treatment with isoniazid (primary or secondary chemoprophylaxis of ITL, or tuberculosis disease treatment); age, weight and total daily dose of isoniazid and basal levels of alanine aminotransferase (ALT-UI/mL) to the initial treatment indication with isoniazid; adherence and adverse events to the treatment with isoniazid.;Timepoint(s) of evaluation of this end point: Patients in monotherapy: 1 or 2 hours post-dose, 3 or 4 hours post-dose, 6 or 8 hours post-dose. In combinate treatment with other drugs anti-TB: Pre-dose, 1 or 2 hours post-dose,3 or 4 hours post-dose, 6 or 8 hours post-dose and 10 or 12 hours post-dose.	—

Measure

Time frame

Secondary end point(s): - Time to the maximum concentration in serum of isoniazid (quantitative variable, in hours). - Minimum concentration in serum of isoniazid (quantitative variable, in mg/L). - Area under the curve of isoniazid concentration in serum (quantitative variable, in mg h/L). From time 0 to 6h (AUC6) and time from 0 to 24h (AUC24) in a posological interval. - Plasmatic clearance of isoniazid (quantitative variable, in L/h) - Apparent distribution volume of isoniazid ( quantitative variable, in liters). - Acetylator genotype (qualitative variable): quick homozygote acetylator, slow homozygote acetylator, or intermediate acetylator. - In patients with tuberculosis disease: disease type (intrathoracic or extratoracic; dichotomic variable) and concomitant treatments with other tuberculostatic drugs (yes/no; dichotomic variable). - Malnutrition (yes/no, dichotomic variable). Defined with weight and/or body mass index lower than -2DS according to the Spanish standar. - Gender, gestational state and weight in the moment of birth, indication about the treatment with isoniazid (primary or secondary chemoprophylaxis of ITL, or tuberculosis disease treatment); age, weight and total daily dose of isoniazid and basal levels of alanine aminotransferase (ALT-UI/mL) to the initial treatment indication with isoniazid; adherence and adverse events to the treatment with isoniazid.;Timepoint(s) of evaluation of this end point: Patients in monotherapy: 1 or 2 hours post-dose, 3 or 4 hours post-dose, 6 or 8 hours post-dose. In combinate treatment with other drugs anti-TB: Pre-dose, 1 or 2 hours post-dose,3 or 4 hours post-dose, 6 or 8 hours post-dose and 10 or 12 hours post-dose.

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Countries

Spain

Contacts

Public ContactUnidad de Puesta en Marcha

SERMES-CRO

start-up@sermescro.com+3491375 69 30

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026