Evidence map›Paper›PMID 24968000›Full record

Trial reportPLoS neglected tropical diseases2014

A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection.

Kwablah Awadzi, Nicholas O Opoku, Simon K Attah, Janis Lazdins-Helds, Annette C Kuesel

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 61 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 2 pooled it
9.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00300768 phase2completednot on this map

A Randomized, Single-Ascending Dose, Ivermectin-Controlled, Double-Blind, Safety, Tolerability, Pharmacokinetic, and Efficacy Study Of Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

TypeinterventionalSponsorMedicines Development for Global HealthRan2006 to 2009Enrolled172ConditionsOnchocerciasisArms2 mg moxidectin, ivermectin 150 mcg/kg, 4 mg moxidectin, 8 mg moxidectin
NCT04188301 phase2completednot on this mapstarted 2019, after this paper: background citation

Safety and Efficacy of Combination Therapy With Ivermectin, Diethylcarbamazine, and Albendazole (IDA) for Individuals With Onchocerciasis

TypeinterventionalSponsorWashington University School of MedicineRan2019 to 2022Enrolled154ConditionsOnchocerciasisArmsIVM w/ ALB, Single dose of IDA, Three daily doses of IDA
NCT06070116 phase2active not recruitingnot on this mapstarted 2024, after this paper: background citation

Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

TypeinterventionalSponsorWashington University School of MedicineRan2024 to 2026Enrolled300ConditionsOnchocercal Subcutaneous Nodule, Onchocerciasis, Onchocerciasis, Ocular, Onchocerca InfectionArmsIvermectin w/ Albendazole, Ivermectin + Diethylcarbamazine + Albendazole, Moxidectin + Albendazole, Moxidectin + Diethylcarbamazine + Albendazole
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 2 syntheses or guidelines pooled it, 238 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Comparison of Repeated Doses of Ivermectin Versus Ivermectin Plus Albendazole for the Treatment of Onchocerciasis: A Randomized, Open-label, Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. An Updated Economic Assessment of Moxidectin Treatment Strategies for Onchocerciasis Elimination.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  20. Review

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Kwablah AwadziOnchocerciasis Chemotherapy Research Centre, Hohoe, Ghana.
Nicholas O OpokuOnchocerciasis Chemotherapy Research Centre, Hohoe, Ghana.
Simon K AttahOnchocerciasis Chemotherapy Research Centre, Hohoe, Ghana; University of Ghana Medical School, Department of Microbiology, Accra, Ghana.
Janis Lazdins-HeldsUNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland.
Annette C KueselUNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland.
Special Programme for Research and Training in Tropical DiseasesUniversity of Ghana · GH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundControl of onchocerciasis as a public health problem in Africa relies on annual mass ivermectin distribution. New tools are needed to achieve elimination of infection. This study determined in a small number of Onchocerca volvulus infected individuals whether moxidectin, a veterinary anthelminthic, is safe enough to administer it in a future large study to further characterize moxidectin's safety and efficacy. Effects on the parasite were also assessed. METHODOLOGY/PRINCIPAL

findingsMen and women from a forest area in South-eastern Ghana without ivermectin mass distribution received a single oral dose of 2 mg (N = 44), 4 mg (N = 45) or 8 mg (N = 38) moxidectin or 150 µg/kg ivermectin (N = 45) with 18 months follow up. All ivermectin and 97%-100% of moxidectin treated participants had Mazzotti reactions. Statistically significantly higher percentages of participants treated with 8 mg moxidectin than participants treated with ivermectin experienced pruritus (87% vs. 56%), rash (63% vs. 42%), increased pulse rate (61% vs. 36%) and decreased mean arterial pressure upon 2 minutes standing still after ≥5 minutes supine relative to pre-treatment (61% vs. 27%). These reactions resolved without treatment. In the 8 mg moxidectin and ivermectin arms, the mean±SD number of microfilariae/mg skin were 22.9±21.1 and 21.2±16.4 pre-treatment and 0.0±0.0 and 1.1±4.2 at nadir reached 1 and 3 months after treatment, respectively. At 6 months, values were 0.0±0.0 and 1.6±4.5, at 12 months 0.4±0.9 and 3.4±4.4 and at 18 months 1.8±3.3 and 4.0±4.8, respectively, in the 8 mg moxidectin and ivermectin arm. The reduction from pre-treatment values was significantly higher after 8 mg moxidectin than after ivermectin treatment throughout follow up (p<0.01). CONCLUSIONS/SIGNIFICANCE: The 8 mg dose of moxidectin was safe enough to initiate the large study. Provided its results confirm those from this study, availability of moxidectin to control programmes could help them achieve onchocerciasis elimination objectives.

trial registrationClinicalTrials.gov NCT00300768.

Indexed as

AdolescentAdultAnimalsAnthelminticsBlood PressureDouble-Blind MethodExanthemaFemaleGhanaHumansIvermectinMacrolidesMaleMicrofilariaeMiddle AgedOnchocerca volvulusAnthelminticsIvermectinMacrolidesmoxidectin

Identifiers

PMID24968000
PMCPMC4072596
OpenAlexW2017410078

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.