Trial Outcomes & Findings for Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi (NCT NCT01213576)

NCT ID: NCT01213576

Last Updated: 2015-02-27

Results Overview

Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2015-02-27

Participant Flow

Participant milestones

Measure	Albendazole 400mg and Ivermectin 200mcg/kg Annually Once a year treatment Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral	Albendazole 800mg and Ivermectin 400mcg/kg Annually Once a year treatment Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral	Albendazole 400mg and Ivermectin 200mcg/kg Biannually Twice a year albendazole 400mg and ivermectin 200mcg/kg given twice a year	Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually Twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Overall Study STARTED	18	17	18	17
Overall Study COMPLETED	15	13	13	13
Overall Study NOT COMPLETED	3	4	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi

Baseline characteristics by cohort

Measure	Albendazole 400mg and Ivermectin 200mcg/kg Annual n=18 Participants Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year	Albendazole 800mg and Ivermectin 400mcg/kg Annual n=17 Participants Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year	Albendazole 400mg and Ivermectin 200mcg/kg Biannual n=18 Participants Albendazole 400mg and ivermectin 200mcg/kg given twice a year	Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual n=17 Participants Albendazole 800mg and ivermectin 400mcg/kg given twice a year	Total n=70 Participants Total of all reporting groups
Age, Continuous	32.5 years n=5 Participants	31 years n=7 Participants	27.5 years n=5 Participants	35 years n=4 Participants	33 years n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	47 Participants n=21 Participants
Region of Enrollment Malawi	18 participants n=5 Participants	17 participants n=7 Participants	18 participants n=5 Participants	17 participants n=4 Participants	70 participants n=21 Participants
Microfilarial count /uL	464.7 microfilaria/uL n=5 Participants	338.7 microfilaria/uL n=7 Participants	204.5 microfilaria/uL n=5 Participants	264.7 microfilaria/uL n=4 Participants	298.6 microfilaria/uL n=21 Participants
HIV status	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Eosinophil count	1300 cells/uL n=5 Participants	1400 cells/uL n=7 Participants	1600 cells/uL n=5 Participants	1100 cells/uL n=4 Participants	1300 cells/uL n=21 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of participants with non detectable microfilaria at follow up

Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.

Outcome measures

Measure	Albendazole 400mg and Ivermectin 200mcg/kg Annually n=18 Participants Once a year treatment Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral	Albendazole 800mg and Ivermectin 400mcg/kg Annually n=17 Participants Once a year treatment Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral	Albendazole 400mg and Ivermectin 200mcg/kg Biannually n=18 Participants Twice a year albendazole 400mg and ivermectin 200mcg/kg given twice a year	Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually n=17 Participants Twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Number of Participants Achieving Microfilarial Clearance	15 participants	14 participants	13 participants	17 participants

SECONDARY outcome

Timeframe: 24 months

Population: Intention to treat, with last result carried forward in the case of missing visit

Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample

Outcome measures

Measure	Albendazole 400mg and Ivermectin 200mcg/kg Annually n=18 Participants Once a year treatment Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral	Albendazole 800mg and Ivermectin 400mcg/kg Annually n=17 Participants Once a year treatment Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral	Albendazole 400mg and Ivermectin 200mcg/kg Biannually n=18 Participants Twice a year albendazole 400mg and ivermectin 200mcg/kg given twice a year	Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually n=17 Participants Twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Number of Participants With Microfilarial Clearance at 24 Months of Follow up	17 participants	17 participants	14 participants	17 participants

Adverse Events

Albendazole 400mg and Ivermectin 200mcg/kg Annually

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Albendazole 800mg and Ivermectin 400mcg/kg Annually

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Albendazole 400mg and Ivermectin 200mcg/kg Biannually

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Albendazole 400mg and Ivermectin 200mcg/kg Annually n=18 participants at risk Once a year treatment Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral	Albendazole 800mg and Ivermectin 400mcg/kg Annually n=17 participants at risk Once a year treatment Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral	Albendazole 400mg and Ivermectin 200mcg/kg Biannually n=18 participants at risk Twice a year albendazole 400mg and ivermectin 200mcg/kg given twice a year	Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually n=17 participants at risk Twice a year Albendazole 800mg and ivermectin 400mcg/kg given twice a year
General disorders Fever	11.1% 2/18	23.5% 4/17	16.7% 3/18	5.9% 1/17
General disorders headache	16.7% 3/18	23.5% 4/17	22.2% 4/18	11.8% 2/17
General disorders joint pains	11.1% 2/18	5.9% 1/17	16.7% 3/18	11.8% 2/17
General disorders abdominal pains	5.6% 1/18	11.8% 2/17	5.6% 1/18	5.9% 1/17

Additional Information

Professor Neil French

University of Liverpool

Phone: +441517959630

Email: french@liv.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place