Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807197019027 Date of Approval: 23/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safety and efficacy of different albendazole-based treatment regimens to reduce microfilaraemia in subjects infected by Loa loa in an Gabon
Official scientific title Safety and efficacy of different albendazole-based treatment regimens to reduce microfilaraemia in subjects infected by Loa loa in an endemic area of Gabon: a randomised controlled open-label pilot study
Brief summary describing the background and objectives of the trial Treatment options for loiasis, a filarial disease caused by infection with Loa loa, are currently limited by the very few drugs of any known efficacy and the risk of severe adverse reactions in patients with high microfilarial loads. Optimisation of regimens for the safe reduction of L. loa microfilaria could contribute to reduction of disease transmission, as well as facilitating elimination campaigns for lymphatic filariasis and onchocerciasis in co-endemic areas. This randomised controlled open-label pilot study will explore the efficacy, sustainability and safety of three albendazole-based treatment regimens for reducing L. loa microfilaraemia in infected subjects in an endemic region of Gabon. Adult male subjects with L. loa microfilarial loads <50,000 mf/mL identified within the ongoing loiasis epidemiology study (BuDiLoLo) in Tsamba-Magotsi department will be eligible for inclusion following provision of written informed consent. Once all (n=42) subjects are recruited, they will be randomised to one of four treatment arms: Arm 1 (n=6) will serve as control, receiving no treatment (=current standard of care); Arm 2 (n=12) will receive a three-week course of albendazole (400mg bid); Arm 3 (n=12) will receive a similar three-week course of albendazole, followed by a second (two-week) course of albendazole at the same time that subjects in Arm 4 are re-treated; Arm 4 will also receive an initial three-week course of albendazole, followed by a single dose (150 ¿g/Kg) of ivermectin as soon as microfilarial loads have dropped to <4,000 mf/mL in >90% of subjects. All subjects will be followed-up intensely during the treatment phase(s) for safety and measurement of microfilarial loads and thereafter every 1-2 weeks up to 6 months. The primary endpoint will be the proportion of subjects who achieve L. loa microfilaraemia of <100 mf/mL at 6 months. Secondary endpoints include safety & tolerability and speed/duration of microfilaricidal effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LoLoTreat
Disease(s) or condition(s) being studied Infections and Infestations,LoaLoa
Sub-Disease(s) or condition(s) being studied Eye infection
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2018
Actual trial start date 15/03/2018
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 15/01/2020
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
CEI-006/2018 IRB-CERMEL
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no intervention no treatment given NA NA 6 Uncontrolled
Experimental Group Albendazole 21 days 400 mg twice daily 21 days Participants will be seen at screening, immediately prior to commencement of the study arm and thereafter daily for the first week, twice per week for the subsequent two weeks for a medication under supervision 12 Active-Treatment of Control Group
Experimental Group Albendazole -Albendazole 400 mg twice daily 35 days Participants will be seen at screening, immediately prior to commencement of the study arm and thereafter daily for the first week, twice per week for the subsequent two weeks for a medication under supervision afterwards participants will be once more daily for the first week and twice par week for the next week 12 Active-Treatment of Control Group
Experimental Group Albendazole and ivermectine 400 mg albendazole twice per day following with single dose of 150 µg/kg of ivermectine 22 days Participants will be seen at screening, immediately prior to commencement of the study arm and thereafter daily for the first week, twice per week for the subsequent two weeks for a medication under supervision afterwards participants will be once more daily for the first week and twice par week for the next week 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Adult, male participants in the BuDiLoLo study -L. loa microfilaria < 50,000 mf/mL -Intention to remain residing in study area and comply with study procedures throughout 6 month follow-up period -Signed written informed consent -Patients treated with albendazole during the 4 previous weeks -Known intolerance or allergy to any study drug -Viral hepatitis (HBV, HCV) or other known active liver disease -HIV or other known immunosuppressive condition -History of epilepsy, encephalitis, meningitis or encephalopathy -Any other acute or chronic medical condition, medication or psychosocial factor(s) deemed by the Investigator to put the potential participant at greater than acceptable risk or to significantly affect study outcomes 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/10/2017 Comite ethique institutionnel du CERMEL
Ethics Committee Address
Street address City Postal code Country
Hopital Albert Sctweitzer-CERMEL-Lambarene-Gabon Lambarene 0242 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary efficacy endpoint will be the proportion of subjects with L. loa microfilarial levels <100 mf/mL at 6 months after the commencement of treatment
Primary Outcome the proportion of subjects without microscopically detectable microfilariae at any time point during follow up.
Secondary Outcome the occurrence of any grade 3 adverse event (AE) or serious adverse event (SAE) from the commencement of each study arm until 6 months thereafter; such events may be related or unrelated to study procedure.
Secondary Outcome be assessed by the occurrence of all (grade 1-2) adverse events at least possibly related to study therapy from the commencement of each study arm until 6 months thereafter.
Secondary Outcome 3. Proportion of subjects without peripheral microfilaraemia at 6 months follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Medicales de Lambarene (CERMEL) Hopital Albert Schweitzer Lambarene 242 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry for education science and research Minoritenplatz 5 Vienna Austria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ayola Akim Adegnika CERMEL Lambarene 242 Gabon University
COLLABORATORS
Name Street address City Postal code Country
Michael Ramharter Hamburg Germany
Rella Zoleko Manego Lambarene Gabon
Ghyslain Mombo-Ngoma Lambarene Gabon
Matthew McCall Lambarene Gabon
Luzia Veletzky Hamburg Germany
Peter G Kremsner Tubingen Germany
Benjamin Mordmüller Tubingen Germany
Wolfram Metzger Tubingen Germany
Heimo Lagler Tubingen Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Ramharter ramharter@bnitm.de +494042818511 Bernhard Nocht 74
City Postal code Country Position/Affiliation
Hamburg Germany professor
Role Name Email Phone Street address
Public Enquiries Michael Ramharter ramharter@bnitm.de +494042818511 Bernhard Nocht 74
City Postal code Country Position/Affiliation
Hamburg Germany professor
Role Name Email Phone Street address
Scientific Enquiries Michael Ramharter ramharter@bnitm.de +494042818511 Bernhard Nocht 74
City Postal code Country Position/Affiliation
Hamburg Germany professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information