Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With… (NCT02184689) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study
Democratic Republic of the Congo125 participantsStarted 2014-05-03
Plain-language summary
The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping sickness in children at least 6 years old and over 20 kg bodyweight.
Who can participate
Age range6 Years – 14 Years
SexALL
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Inclusion Criteria:
* Informed consent form signed by one of the parents or the child's legal representative
* Child assent to participate in the study collected in the presence of an impartial witness
* Age between 6 and 15 years old
* \> 20 Kg bodyweight
* Boy or girl
* Able to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
* Able to swallow 600mg fexinidazole tablets
* Karnofsky index \> 50
* Presence of trypanosomes in blood and/or lymph and/or CSF
* Permanent address and ability to comply with follow-up visit schedule
Exclusion Criteria:
* Child refusing to be included in the trial
* Bodyweight \< 20 Kg
* Severe malnutrition, defined as having a BMI below 16 (- 2 Z-score of the norm according to WHO 2007 Growth reference data)
* Inability to take oral medication
* Pregnancy or breastfeeding
* Clinically relevant medical condition other than HAT that, in the Investigator's opinion, may jeopardize subject safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular disease, active documented or suspected infection, central nervous system (CNS) trauma or seizure disorders, coma or altered consciousness
* Severely deteriorated general condition, such as cardiovascular shock, respiratory distress, or terminal illness
* Any medical condition (except HAT-specific symptoms) hindering communication with the Investigator as required for the completion of this study
* Any contraindication to…
What they're measuring
1
Outcome (success or failure) at the test of cure (ToC)