Assessment of an abridged melarsoprol treatment schedule against late stage Trypanosoma brucei rhodesiense sleeping sickness, multinational phase II study (proof of concept)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40537886

Enrollment

Registered

2006-04-03

Start date

2006-05-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

T.b. rhodesiense second stage trypanosomiasis Infections and Infestations T.b. rhodesiense second stage trypanosomiasis

Interventions

New drug treatment schedule for melarsoprol with or without standard pre-treatment with suramin.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient recruitment through: 1. Active surveillance in high prevalence villages 2. Passive case detection Inclusion criteria: 1. Patients of either sex with second stage T.b. rhodesiense infection 2. Six years of age or older 3. Must provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with first stage T.b. rhodesiense infection i.e. presence of trypanosomes in blood upon microscopic examination and no trypanosomes in cerebrospinal fluid (CSF) and/or white blood cell count (WBC) less or equal to 5 cells per mm^3 2. Moribund or unconscious patients at less than 8 points on the Glasgow coma scale 3. Pregnancy 4. Active clinically relevant medical conditions that in the investigators opinion may jeopardise subject safety or interfere with participation in the study, including but not limited to: significant liver disease, chronic pulmonary disease, significant cardiovascular disease, diabetes and open tuberculosis 5. Critically ill patients with any condition which necessitates immediate and concomitant treatment not listed above 6. The subject has been previously enrolled in the study

Design outcomes

Primary

Measure	Time frame
1. Efficacy: parasitological and clinical cure 24 hours after treatment 2. Safety: determined by a combined endpoint of serious adverse drug reactions with fatal outcome and other causes of death (e.g. disease-related opportunistic infections). The assessment of safety through the end of treatment evaluation, measurement of vital signs, physical examinations and the use of concomitant medications is included. Adverse events which are spontaneously reported between the end of treatment evaluation and 30 days post-treatment will also be collected.	—

Measure

Time frame

1. Efficacy: parasitological and clinical cure 24 hours after treatment 2. Safety: determined by a combined endpoint of serious adverse drug reactions with fatal outcome and other causes of death (e.g. disease-related opportunistic infections). The assessment of safety through the end of treatment evaluation, measurement of vital signs, physical examinations and the use of concomitant medications is included. Adverse events which are spontaneously reported between the end of treatment evaluation and 30 days post-treatment will also be collected.

—

Secondary

Measure	Time frame
Parasitological and clinical cure 3, 6 and 12 months after completion of treatment and relapse, re-infection and death	—

Countries

Tanzania, Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026