Death to Onchocerciasis and Lymphatic Filariasis: Comparison of Ivermectin alone with Albendazole (ALB) plus Ivermectin (IVM) in their efficacy against Onchocerciasis

Comparison of Ivermectin alone with Albendazole (ALB) plus Ivermectin (IVM) in their efficacy against Onchocerciasis: a randomised open label trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50035143

Enrollment

272

Registered

2012-10-18

Start date

2012-10-10

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Onchocerciasis (Onchocerca volvulus) Infections and Infestations Onchocerciasis

Interventions

Treatment regimen 1: The comparator (standard treatment): Ivermectin 200 µg/kg body weight given at 0, 12 and 24 months (annually) plus vitamin pills at 6 and 18 months. (n = 68) Trea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment: 1. Men and women 18-60 years residing in Ashanti and Central Regions of Ghana 2. =1 accessible nodules 3. Any Mf based on skin snips Previous inclusion criteria: 1. Men and women 18-60 years residing in Central Region of Ghana 2. =1 accessible nodules 3. =5 Mf/mg based on skin snips

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment: 1. Last IVM treatment 1.5 upper limit of normal 6. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose) Previous exclusion criteria: 1. Last IVM treatment 1.5 upper limit of normal 6. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)

Design outcomes

Primary

Measure	Time frame
Percent fertile female adult worms in accessible nodules at 36 months following initiation of therapy	—

Secondary

Measure	Time frame
1. Percent reduction in skin Mf/mg at 0, 6, 18, and 36 months after initiation of therapy. 2. Percent reduction in total number of live versus dead female worms in nodules at 36 months following initiation of therapy. 3. The number of nodules with intact microfilariae (Mf) at 36 months following initiation of therapy. 4. Assessment of the different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools.	—

Measure

Time frame

1. Percent reduction in skin Mf/mg at 0, 6, 18, and 36 months after initiation of therapy. 2. Percent reduction in total number of live versus dead female worms in nodules at 36 months following initiation of therapy. 3. The number of nodules with intact microfilariae (Mf) at 36 months following initiation of therapy. 4. Assessment of the different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools.

—

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026